NDC 33261-048

Gabapentin

Gabapentin

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

Product ID33261-048_aeb1540b-a797-44b1-9964-28ddfba18b4f
NDC33261-048
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-11-24
Marketing CategoryANDA / ANDA
Application NumberANDA078428
Labeler NameAidarex Pharmaceuticals LLC
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 Through2019-12-31

Packaging

NDC 33261-048-60

60 CAPSULE in 1 BOTTLE (33261-048-60)
Marketing Start Date2009-11-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-048-10 [33261004810]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-20 [33261004820]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-45 [33261004845]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-30 [33261004830]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-21 [33261004821]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-97 [33261004897]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-81 [33261004881]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-90 [33261004890]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-00 [33261004800]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-99 [33261004899]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-60 [33261004860]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

NDC 33261-048-02 [33261004802]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN100 mg/1

OpenFDA Data

SPL SET ID:cd2d3b9d-09cc-4342-9888-9b2e792a51ee
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.