0603-5371 NDC - PRIMIDONE (PRIMIDONE)
Product NDC: 0603-5371
Proprietary Name: Primidone
Non Proprietary Name: primidone
Administration Route(s): ORAL
Dosage Form(s): TABLET
- Anti-epileptic Agent [EPC];
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
||HUMAN PRESCRIPTION DRUG
|FDA Application Number:
|Start Marketing Date:||2/24/2005|
||10 TABLET in 1 BOTTLE, PLASTIC (0603-5371-10)
||100 TABLET in 1 BOTTLE, PLASTIC (0603-5371-21)
||500 TABLET in 1 BOTTLE, PLASTIC (0603-5371-28)
||1000 TABLET in 1 BOTTLE, PLASTIC (0603-5371-32)
||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.
||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.
||Also known as the trade name. It is the name of the product chosen by the labeler.
||NON PROPRIETARY NAME
||Sometimes called the generic name, this is usually the active ingredient(s) of the product.
||DOSAGE FORM NAME
||The translation of the DosageForm Code submitted by the firm.
||The translation of the Route Code submitted by the firm, indicating route of administration.
||START MARKETING DATE
||This is the date that the labeler indicates was the start of its marketing of the drug product.
||MARKETING CATEGORY NAME
||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.
||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.
||Name of Company corresponding to the labeler code segment of the Product NDC.
||This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
||ACTIVE NUMERATOR STRENGTH
||ACTIVE INGRED UNIT
||Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
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This page was last updated on: 1/13/2016