NDC 53002-1472

GABAPENTIN

Gabapentin

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

Product ID53002-1472_5d6bd69c-3c85-4cd2-b18d-712580d43454
NDC53002-1472
Product TypeHuman Prescription Drug
Proprietary NameGABAPENTIN
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-06-29
Marketing CategoryANDA / ANDA
Application NumberANDA090705
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameGABAPENTIN
Active Ingredient Strength100 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 53002-1472-0

100 CAPSULE in 1 BOTTLE (53002-1472-0)
Marketing Start Date2017-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1472-6 [53002147206]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1472-0 [53002147200]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1472-3 [53002147203]

GABAPENTIN CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN100 mg/1

OpenFDA Data

SPL SET ID:783af1df-dbcc-41c9-bbd6-fcb3d2838153
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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.