NDC 76282-321

GABAPENTIN

Gabapentin

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

Product ID76282-321_923f7861-e4d8-4b87-8587-fc075b561653
NDC76282-321
Product TypeHuman Prescription Drug
Proprietary NameGABAPENTIN
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA090705
Labeler NameExelan Pharmaceuticals, Inc.
Substance NameGABAPENTIN
Active Ingredient Strength100 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 76282-321-01

100 CAPSULE in 1 BOTTLE (76282-321-01)
Marketing Start Date2010-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76282-321-18 [76282032118]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-20

NDC 76282-321-90 [76282032190]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-20

NDC 76282-321-27 [76282032127]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-20

NDC 76282-321-01 [76282032101]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-26

NDC 76282-321-05 [76282032105]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-26

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN100 mg/1

OpenFDA Data

SPL SET ID:41d1ead3-046e-4abf-ae0a-cb126a1f5848
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310432
  • 310431
  • 310430
    • UPC Code
  • 0376282322902
  • 0376282323909
  • 0376282627908
  • 0376282321905

    • 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 "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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