NDC 0603-5372

Primidone

Primidone

Primidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Primidone.

• Product ID: 0603-5372_1c33caad-ce65-4bde-a5cd-cada812bfbc5
• NDC: 0603-5372
• Product Type: Human Prescription Drug
• Proprietary Name: Primidone
• Generic Name: Primidone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2005-02-24
• Marketing End Date: 2021-09-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040586
• Labeler Name: Par Pharmaceutical
• Substance Name: PRIMIDONE
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N

Packaging

NDC 0603-5372-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-5372-21)

• Marketing Start Date: 2005-02-24
• Marketing End Date: 2021-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0603-5372-28 [00603537228]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA040586
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-02-24
• Marketing End Date: 2021-09-30

NDC 0603-5372-21 [00603537221]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA040586
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-02-24
• Marketing End Date: 2021-09-30

NDC 0603-5372-32 [00603537232]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA040586
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-02-24
• Marketing End Date: 2017-06-01

NDC 0603-5372-10 [00603537210]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA040586
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-02-24
• Marketing End Date: 2017-06-01

Drug Details

Active Ingredients

Ingredient	Strength
PRIMIDONE	250 mg/1

OpenFDA Data

• SPL SET ID: cce71bdb-1018-4f94-90d4-cf3cc804fbb3
• Manufacturer:
  • Par Pharmaceutical
• UNII:
  • 13AFD7670Q
• RxNorm Concept Unique ID - RxCUI:
  • 198150
  • 96304
• UPC Code:
  • 0306035371215
  • 0306035372212

Pharmacological Class

• Anti-epileptic Agent [EPC]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC Crossover Matching brand name "Primidone" or generic name "Primidone"

NDC	Brand Name	Generic Name
0143-1482	Primidone	Primidone
0143-1484	Primidone	Primidone
0527-1231	Primidone	Primidone
0527-1301	Primidone	Primidone
0591-5321	Primidone	Primidone
0603-5371	Primidone	primidone
0603-5372	Primidone	primidone
0615-2521	Primidone	primidone
0615-5591	Primidone	Primidone
0615-7738	Primidone	Primidone
0615-7936	Primidone	primidone
0615-8206	Primidone	Primidone
0904-5559	Primidone	Primidone
10135-522	Primidone	Primidone
10135-540	Primidone	Primidone
42291-508	Primidone	primidone
42291-509	Primidone	Primidone
42291-511	Primidone	Primidone
50090-1622	Primidone	Primidone
50090-1636	Primidone	Primidone
50090-4083	Primidone	Primidone
50268-686	Primidone	Primidone
50268-687	Primidone	Primidone
51407-637	Primidone	Primidone
51407-638	Primidone	Primidone
53746-544	Primidone	Primidone
68084-203	Primidone	Primidone
68084-202	Primidone	Primidone
68682-690	Primidone	Primidone
68682-691	Primidone	Primidone
71610-191	Primidone	Primidone
71610-005	Primidone	Primidone
71610-079	Primidone	Primidone
53746-545	Primidone	Primidone
55111-477	Primidone	Primidone
55111-476	Primidone	Primidone
63629-7811	Primidone	Primidone
65162-544	Primidone	Primidone
65162-545	Primidone	Primidone
71335-1158	Primidone	Primidone