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  4. NDC Product Code: 0904-7080 Nifedipine

NDC 0904-7080 Nifedipine

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0904-7080?
  4. Nifedipine Uses
  5. NDC to RxNorm Crosswalk

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) 0904-7080 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:
0904-7080
Proprietary Name:
Nifedipine
Product Type: [3]
Labeler Name: [5]
Major Pharmaceuticals
Labeler Code:
0904
Product Label ID:
41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9
FDA Application Number: [6]
ANDA210614
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
03-12-2019
End Marketing Date: [10]
09-30-2022
Listing Expiration Date: [11]
09-30-2022
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 0904-7080?

The NDC code 0904-7080 is assigned by the FDA to the product Nifedipine which is product labeled by Major Pharmaceuticals. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 0904-7080-06 50 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack, 0904-7080-61 100 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack. 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 Nifedipine?

This medication is used to prevent certain types of chest pain (angina). It may allow you to exercise more and decrease the frequency of angina attacks. Nifedipine belongs to a class of medications known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. This medication must be taken regularly to be effective. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor. Consult your doctor or pharmacist for details. Older adults should discuss the risks and benefits of this medication with their doctor or pharmacist, as well as other possibly safer forms of nifedipine (such as the long-acting tablets).

What is the NDC to RxNorm Crosswalk for Nifedipine?

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: 1812011 - NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet
  • RxCUI: 1812011 - Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet
  • RxCUI: 1812011 - nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet
  • RxCUI: 1812013 - NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet
  • RxCUI: 1812013 - Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet

* 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".