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
1 PRODUCT NDC 0603-5371
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG
3 PROPRIETARY NAME Primidone
4 NON PROPRIETARY NAME primidone
5 DOSAGE FORM NAME TABLET
6 ROUTE NAME ORAL
7 START MARKETING DATE 2/24/2005
8 MARKETING CATEGORY NAME ANDA
9 APPLICATION NUMBER ANDA040586
10 LABELER NAME Qualitest Pharmaceuticals
11 SUBSTANCE NAME PRIMIDONE
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: 8/22/2014