NDC 10135-522

Primidone

Primidone

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

• Product ID: 10135-522_5c03bef5-3f96-4ecd-ba3d-a9c3f35dede1
• NDC: 10135-522
• Product Type: Human Prescription Drug
• Proprietary Name: Primidone
• Generic Name: Primidone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-05-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA084903
• Labeler Name: Marlex Pharmaceuticals Inc
• 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
• Listing Certified Through: 2020-12-31

Packaging

NDC 10135-522-01

100 TABLET in 1 BOTTLE (10135-522-01)

• Marketing Start Date: 2015-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10135-522-10 [10135052210]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA084903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-05-01

NDC 10135-522-05 [10135052205]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA084903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-05-01

NDC 10135-522-01 [10135052201]

Primidone TABLET

• Marketing Category: ANDA
• Application Number: ANDA084903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-05-01

Drug Details

Active Ingredients

Ingredient	Strength
PRIMIDONE	250 mg/1

OpenFDA Data

• SPL SET ID: 934a6d96-6da2-4fba-bf1f-08e7acbf59bc
• Manufacturer:
  • Marlex Pharmaceuticals Inc
• UNII:
  • 13AFD7670Q
• RxNorm Concept Unique ID - RxCUI:
  • 198150
  • 96304

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