NDC 68071-4099

Gabapentin

Gabapentin

Gabapentin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Gabapentin.

Product ID68071-4099_7e56ccbf-8f95-166a-e053-2991aa0a5ff5
NDC68071-4099
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-01-11
Marketing CategoryANDA / ANDA
Application NumberANDA203244
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameGABAPENTIN
Active Ingredient Strength600 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-4099-2

120 TABLET, FILM COATED in 1 BOTTLE (68071-4099-2)
Marketing Start Date2017-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4099-8 [68071409908]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203244
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

NDC 68071-4099-7 [68071409907]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203244
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

NDC 68071-4099-9 [68071409909]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203244
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

NDC 68071-4099-4 [68071409904]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203244
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

NDC 68071-4099-2 [68071409902]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203244
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

NDC 68071-4099-6 [68071409906]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203244
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

NDC 68071-4099-3 [68071409903]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203244
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN600 mg/1

OpenFDA Data

SPL SET ID:598e9653-9331-3bfe-e053-2a91aa0afcbe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310433
  • UPC Code
  • 0368071409994
  • 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
    0228-2636GabapentinGabapentin
    0228-2637GabapentinGabapentin
    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

    © 2021 FDA.report
    This site is not affiliated with or endorsed by the FDA.