NDC 11788-027 Benzonatate
Capsule Oral

Product Information

What is NDC 11788-027?

The NDC code 11788-027 is assigned by the FDA to the product Benzonatate which is a human prescription drug product labeled by Aiping Pharmaceutical, Inc.. The product's dosage form is capsule and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 11788-027-00 24000 capsule in 1 carton , 11788-027-01 100 capsule in 1 bottle , 11788-027-05 500 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code11788-027
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Benzonatate
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Benzonatate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormCapsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Aiping Pharmaceutical, Inc.
Labeler Code11788
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ANDA210562
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-14-2019
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Benzonatate?


Product Characteristics

Color(s)YELLOW (C48330)
ShapeCAPSULE (C48336)
Size(s)9 MM
10 MM
11 MM
Imprint(s)LOGO;28
LOGO;29
LOGO;27
Score1

Product Packages

NDC Code 11788-027-00

Package Description: 24000 CAPSULE in 1 CARTON

NDC Code 11788-027-01

Package Description: 100 CAPSULE in 1 BOTTLE

NDC Code 11788-027-05

Package Description: 500 CAPSULE in 1 BOTTLE

Product Details

What are Benzonatate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Benzonatate Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Benzonatate Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Benzonatate Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Description



Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7.

C 30H 53NO 11

Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben and propylparaben. Imprinting ink is composed of isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, and titanium dioxide.


Clinical Pharmacology



Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.


Indications And Usage



Benzonatate USP is indicated for the symptomatic relief of cough.


Contraindications



Hypersensitivity to benzonatate or related compounds.


Warnings



Hypersensitivity

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.

Psychiatric Efects

Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).


Precautions



Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.


Information For Patients



Information for Patients Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate Capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.

Overdosage resulting in death may occur in adults.

Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsule, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.


Usage In Pregnancy



PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with benzonatate. It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate should be given to a pregnant woman only if clearly needed.


Nursing Mothers



Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when benzonatate is administered to a nursing woman.


Carcinogenesis & Mutagenesis & Impairment Of Fertility



Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.


Pediatric Use



Pediatric Use

Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.


Adverse Reactions



Potential Adverse Reactions to benzonatate may include:

Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.

GI: constipation; nausea; GI upset.

Dermatologic: pruritus; skin eruptions.

Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.


Overdosage



Intentional and unintentional overdose may result in death, particularly in children. The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms

The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.

Treatment

In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage. Do not use CNS stimulants.


Dosage And Administration



Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.


How Supplied



Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "

"with white ink, quantity of 44,000 capsules (NDC 11788-028-00)

Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted " "with white ink, quantity of 32,000 capsules (NDC 11788-029-00)

Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted " "with white ink, quantity of 24,000 capsules (NDC 11788-027-00)

Store at room temperature 15-30°C

Manufacturer:

Anishi Pharmaceutical (Zhongshan) Inc.

National Health Technology Park, Zhongshan, Guangdong. China

For:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788 USA


Principal Display Panel - Shipping Label



Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788, USA

Manufactured by:

Anshi Pharamceutical (Zhongshan) Inc.

National Health Technology Park

Zhongshan, Guangdong, China

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

Benzonatate Capsules, USP 100 mg

Quantity: 44,000 Capsules

NDC 11788-028-00

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788, USA

Manufactured by:

Anshi Pharamceutical (Zhongshan) Inc.

National Health Technology Park

Zhongshan, Guangdong, China

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

Benzonatate Capsules, USP 150mg

Quantity: 32,000 Capsules

NDC 11788-029-00

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788, USA

Manufactured by:

Anshi Pharamceutical (Zhongshan) Inc.

National Health Technology Park

Zhongshan, Guangdong, China

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

Benzonatate Capsules, USP 200mg

Quantity: 24,000 Capsules

NDC 11788-027-00


* Please review the disclaimer below.