NDC 71610-079

Primidone

Primidone

Primidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Primidone.

• Product ID: 71610-079_2d04438d-30db-4621-aa15-03b25aa283ff
• NDC: 71610-079
• Product Type: Human Prescription Drug
• Proprietary Name: Primidone
• Generic Name: Primidone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-03-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040586
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: PRIMIDONE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71610-079-60

90 TABLET in 1 BOTTLE, PLASTIC (71610-079-60)

• Marketing Start Date: 2018-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71610-079-80 [71610007980]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA040586
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-31

NDC 71610-079-94 [71610007994]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA040586
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-31

NDC 71610-079-60 [71610007960]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA040586
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-31

Drug Details

Active Ingredients

Ingredient	Strength
PRIMIDONE	50 mg/1

OpenFDA Data

• SPL SET ID: 3e081b24-20f5-4ffd-b493-771fd4ac2c96
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 13AFD7670Q
• RxNorm Concept Unique ID - RxCUI:
  • 198150

Pharmacological Class

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