NDC 43353-190

GABAPENTIN

Gabapentin

GABAPENTIN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Gabapentin.

Product ID43353-190_0fff2a2a-4229-4cef-9ea1-d0c63e9c2821
NDC43353-190
Product TypeHuman Prescription Drug
Proprietary NameGABAPENTIN
Generic NameGabapentin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-11-02
Marketing CategoryANDA / ANDA
Application NumberANDA202764
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameGABAPENTIN
Active Ingredient Strength800 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 43353-190-45

45 TABLET, FILM COATED in 1 BOTTLE (43353-190-45)
Marketing Start Date2020-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-190-70 [43353019070]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-22

NDC 43353-190-92 [43353019092]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-25

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN800 mg/1

OpenFDA Data

SPL SET ID:11da2692-fb0a-4519-b8a4-323c7a6eeb4d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310434

    • 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.