NDC 43378-103 Zodryl Ac 40

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 43378-103 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
43378-103
Proprietary Name:
Zodryl Ac 40
Product Type: [3]
Labeler Name: [5]
Labeler Code:
43378
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
08-24-2009
End Marketing Date: [10]
09-11-2009
Listing Expiration Date: [11]
09-11-2009
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
RED (C48326)
Flavor(s):
GRAPE (C73391)

Code Structure Chart

Product Details

What is NDC 43378-103?

The NDC code 43378-103 is assigned by the FDA to the product Zodryl Ac 40 which is product labeled by Codadose, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 43378-103-04 118 ml in 1 bottle, plastic , 43378-103-04 118 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Zodryl Ac 40?

This product is used as Temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants; the intensity of coughing; the impulse to cough to help you go to sleep; temporarily decreases runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergiesWarnings

Which are Zodryl Ac 40 UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Zodryl Ac 40 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Zodryl Ac 40?

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:
  • RxCUI: 995068 - codeine phosphate 1 MG / chlorpheniramine maleate 0.222 MG per 1 mL Oral Suspension
  • RxCUI: 995068 - chlorpheniramine maleate 0.222 MG/ML / codeine phosphate 1 MG/ML Oral Suspension
  • RxCUI: 995068 - chlorpheniramine maleate 0.222 MG / codeine phosphate 1 MG per 1 ML Oral Suspension
  • RxCUI: 995070 - Zodryl AC 40, 1 MG / 0.222 MG per 1 mL Oral Suspension
  • RxCUI: 995070 - chlorpheniramine maleate 0.222 MG/ML / codeine phosphate 1 MG/ML Oral Suspension [Zodryl AC]

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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] 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".