Nifedipine
NDC 67046-515
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Nifedipine is a NDA-approved product labeled by Contract Pharmacy Services-pa. This medication is used to prevent certain types of chest pain (angina). It is supplied as a pink product. This product entry covers the primary NDC 67046-515 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
67046-515
Proprietary Name:
Nifedipine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
67046
Product Label ID:
FDA Application Number: [6]
NDA019684
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
04-13-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Product Characteristics
Color(s):
PINK (C48328 - ROSE-PINK)
Shape:
ROUND (C48348)
Size(s):
9 MM
Imprint(s):
M;475
Score:
1
Code Structure Chart
Product Details
What is NDC 67046-515?
The NDC code 67046-515 is assigned by the FDA to the product Nifedipine. This pharmaceutical product is labeled by Contract Pharmacy Services-pa and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 67046-515-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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).
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- NIFEDIPINE (UNII: I9ZF7L6G2L)
- NIFEDIPINE (UNII: I9ZF7L6G2L) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".
