0603-5371 NDC - PRIMIDONE (PRIMIDONE)

Drug Information

Product NDC: 0603-5371

Proprietary Name: Primidone

Non Proprietary Name: primidone

Active Ingredient(s):
  • 50 mg/1 PRIMIDONE


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Anti-epileptic Agent [EPC];
  • Decreased Central Nervous System Disorganized Electrical Activity [PE]

Labeler Information

Labeler Name: Qualitest Pharmaceuticals
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040586
Marketing Category: ANDA
Start Marketing Date:2/24/2005

Package Information

No. Package Code Package Description
1 0603-5371-10 10 TABLET in 1 BOTTLE, PLASTIC (0603-5371-10)
2 0603-5371-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-5371-21)
3 0603-5371-28 500 TABLET in 1 BOTTLE, PLASTIC (0603-5371-28)
4 0603-5371-32 1000 TABLET in 1 BOTTLE, PLASTIC (0603-5371-32)

NDC Record

No. Field Name Field Value Field Definition
1 PRODUCT NDC 0603-5371 The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
3 PROPRIETARY NAME Primidone Also known as the trade name. It is the name of the product chosen by the labeler.
4 NON PROPRIETARY NAME primidone Sometimes called the generic name, this is usually the active ingredient(s) of the product.
5 DOSAGE FORM NAME TABLET The translation of the DosageForm Code submitted by the firm.
6 ROUTE NAME ORAL The translation of the Route Code submitted by the firm, indicating route of administration.
7 START MARKETING DATE 2/24/2005 This is the date that the labeler indicates was the start of its marketing of the drug product.
8 MARKETING CATEGORY NAME ANDA 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 APPLICATION NUMBER ANDA040586 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.
10 LABELER NAME Qualitest Pharmaceuticals Name of Company corresponding to the labeler code segment of the Product NDC.
11 SUBSTANCE NAME PRIMIDONE This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
12 ACTIVE NUMERATOR STRENGTH 50
13 ACTIVE INGRED UNIT mg/1
14 PHARM CLASSES Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

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This page was last updated on: 7/17/2015