NDC 62584-813 Oxazepam
Capsule, Gelatin Coated Oral

Product Information

Product Code62584-813
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.
Oxazepam
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.
Oxazepam
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, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
American Health Packaging
Labeler Code62584
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.
ANDA072253
DEA Schedule What is the Drug Enforcement Administration (DEA) CIV Schedule?
The controlled substances in the CIV schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the United States.
Schedule IV (CIV) Substances
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.
07-31-2007
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.
12-31-2022
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

Usage Information


Product Characteristics

Color(s)PINK (C48328 - OPAQUE)
RED (C48326 - OPAQUE)
ShapeCAPSULE (C48336)
Size(s)14 MM
Imprint(s)R;067
R;069
Score1

Product Packages

NDC 62584-813-01

Package Description: 100 BLISTER PACK in 1 CARTON > 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (62584-813-11)

Price per Unit: $1.08888 per EA

Product Details

Oxazepam is a human prescription drug product labeled by American Health Packaging. The product's dosage form is capsule, gelatin coated and is administered via oral form.


What are Oxazepam Active Ingredients?

The following is the list of active ingredients in this product. 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.


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:


Inactive Ingredient(s)

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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)


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.

Patient Education

Oxazepam

Oxazepam is pronounced as (ox a' ze pam)

Why is oxazepam medication prescribed?
Oxazepam is used to relieve anxiety, including anxiety caused by alcohol withdrawal (symptoms that may develop in people who stop drinking alcohol after drinking large am...
[Read More]

* Please review the disclaimer below.

Oxazepam Labeling and Warnings

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.

Table of Contents



Packaging Information



American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Actavis Pharma, Inc. as follows:
(10 mg / 100 UD) NDC 62584-812-01 packaged from NDC 0228-2067
(15 mg / 100 UD) NDC 62584-813-01 packaged from NDC 0228-2069
(30 mg / 100 UD) NDC 62584-814-01 packaged from NDC 0228-2073

Distributed by:
American Health Packaging
Columbus, OH 43217

8081301/0417


Package/Label Display Panel – Carton – 10 Mg



NDC 62584-812-01

Oxazepam
Capsules, USP

CIV

10 mg

100 Capsules (10 x 10)

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Capsule Contains:
Oxazepam, USP ............................................. 10 mg

Usual Dosage See package insert for full prescribing information.

Store at 25°C (77°F); excursions permitted between 15° to 30°C
(59° to 86°F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Rx Only

The drug product contained in this package is from
NDC # 0228-2067, Actavis Pharma, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

100104
0081201/0517


Package/Label Display Panel – Blister – 10 Mg



Oxazepam
Capsule, USP

CIV

10 mg


Package/Label Display Panel – Carton – 15 Mg



NDC 62584-813-01

Oxazepam
Capsules, USP

CIV

15 mg

100 Capsules (10 x 10)

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Capsule Contains:
Oxazepam, USP ............................................. 15 mg

Usual Dosage See package insert for full prescribing information.

Store at 25°C (77°F); excursions permitted between 15° to 30°C
(59° to 86°F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Rx Only

The drug product contained in this package is from
NDC # 0228-2069, Actavis Pharma, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

100119
0081301/0417


Package/Label Display Panel – Blister – 15 Mg



Oxazepam
Capsule, USP

CIV

15 mg


Package/Label Display Panel – Carton – 30 Mg



NDC 62584-814-01

Oxazepam
Capsules, USP

CIV

30 mg

100 Capsules (10 x 10)

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Capsule Contains:
Oxazepam, USP ............................................. 30 mg

Usual Dosage See package insert for full prescribing information.

Store at 25°C (77°F); excursions permitted between 15° to 30°C
(59° to 86°F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Rx Only

The drug product contained in this package is from
NDC # 0228-2073, Actavis Pharma, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

100125
0081401/0417


Package/Label Display Panel – Blister – 30 Mg



Oxazepam
Capsule, USP

CIV

30 mg


* Please review the disclaimer below.