NDC 0904-5632

Gabapentin

Gabapentin

Gabapentin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Gabapentin.

Product ID0904-5632_d2dd7fa1-6756-474d-8eb9-10efed51dfdf
NDC0904-5632
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2005-04-06
Marketing End Date2019-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA075360
Labeler NameMajor Pharmaceuticals
Substance NameGABAPENTIN
Active Ingredient Strength300 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN

Packaging

NDC 0904-5632-61

100 BLISTER PACK in 1 CARTON (0904-5632-61) > 1 CAPSULE in 1 BLISTER PACK
Marketing Start Date2005-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-5632-53 [00904563253]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-06
Marketing End Date2016-03-30

NDC 0904-5632-89 [00904563289]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-06
Marketing End Date2016-02-28

NDC 0904-5632-93 [00904563293]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-06
Marketing End Date2016-02-28

NDC 0904-5632-61 [00904563261]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-06
Marketing End Date2019-06-30

NDC 0904-5632-52 [00904563252]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-06
Marketing End Date2016-03-31

NDC 0904-5632-40 [00904563240]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-06
Marketing End Date2016-01-13

NDC 0904-5632-46 [00904563246]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-06
Marketing End Date2016-04-30

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN300 mg/1

OpenFDA Data

SPL SET ID:7b7e9d25-c6d4-43aa-9e0a-5427ed2ebdaf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310432
  • 310431
  • 310430

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-4443GabapentinGabapentin
    0093-4444GabapentinGabapentin
    0143-3991GabapentinGabapentin
    0143-3993GabapentinGabapentin
    0143-3994GabapentinGabapentin
    0143-9992GabapentinGabapentin
    0143-9993GabapentinGabapentin
    0143-9994GabapentinGabapentin
    67877-222GabapentinGabapentin
    67877-223GabapentinGabapentin
    67877-224GabapentinGabapentin
    67877-428GabapentinGabapentin
    67877-429GabapentinGabapentin
    68001-006GabapentinGabapentin
    68001-007GabapentinGabapentin
    68071-1212GABAPENTINGABAPENTIN
    68071-1292GabapentinGabapentin
    68071-1808GABAPENTINGABAPENTIN
    68071-1907GABAPENTINGABAPENTIN
    68071-1995GabapentinGabapentin
    68071-3230GABAPENTINGABAPENTIN
    68071-3046GabapentinGabapentin
    68071-3244GabapentinGabapentin
    68071-4087GabapentinGabapentin
    68071-3086GABAPENTINGABAPENTIN
    68071-3383GABAPENTINGABAPENTIN
    68071-3314GABAPENTINGABAPENTIN
    68071-4049GABAPENTINGABAPENTIN
    68071-4241GABAPENTINGABAPENTIN
    68071-4099GabapentinGabapentin
    68071-4113GabapentinGabapentin
    68071-4292GabapentinGabapentin
    68071-4180GabapentinGabapentin
    68071-4090GabapentinGabapentin
    68071-4329GabapentinGabapentin
    68071-4603GabapentinGabapentin
    68071-4169GabapentinGabapentin
    68071-4346GabapentinGabapentin
    68071-4366GabapentinGabapentin
    68071-4729GabapentinGabapentin
    68071-4402GABAPENTINGABAPENTIN
    68071-4784GABAPENTINGABAPENTIN
    68084-774GabapentinGabapentin
    68084-783GabapentinGabapentin
    68084-797GabapentinGabapentin
    68084-762GabapentinGabapentin
    0440-5562GABAPENTINGABAPENTIN
    0440-5563GABAPENTINGABAPENTIN
    68084-802GabapentinGabapentin
    68151-1028GabapentinGabapentin
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