NDC 71335-1158

Primidone

Primidone

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

Product ID71335-1158_1414ad7c-26e8-43f6-b211-d102eba1d1c4
NDC71335-1158
Product TypeHuman Prescription Drug
Proprietary NamePrimidone
Generic NamePrimidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA084903
Labeler NameBryant Ranch Prepack
Substance NamePRIMIDONE
Active Ingredient Strength50 mg/1
Pharm ClassesAnti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1158-1

30 TABLET in 1 BOTTLE (71335-1158-1)
Marketing Start Date2021-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1158-3 [71335115803]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-27

NDC 71335-1158-2 [71335115802]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-27

NDC 71335-1158-1 [71335115801]

Primidone TABLET
Marketing CategoryANDA
Application NumberANDA084903
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-27

Drug Details

Active Ingredients

IngredientStrength
PRIMIDONE50 mg/1

OpenFDA Data

SPL SET ID:1414ad7c-26e8-43f6-b211-d102eba1d1c4
Manufacturer
UNII

Pharmacological Class

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

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

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