NDC 0093-4443

Gabapentin

Gabapentin

Gabapentin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Gabapentin.

Product ID0093-4443_76e073b2-ef68-479a-938e-417338fc4105
NDC0093-4443
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-07-11
Marketing End Date2019-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA076017
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameGABAPENTIN
Active Ingredient Strength600 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN

Packaging

NDC 0093-4443-01

100 TABLET in 1 BOTTLE (0093-4443-01)
Marketing Start Date2008-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-4443-01 [00093444301]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA076017
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-11
Marketing End Date2019-04-30

NDC 0093-4443-10 [00093444310]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA076017
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-08-01
Marketing End Date2019-04-30

NDC 0093-4443-05 [00093444305]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA076017
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-03
Marketing End Date2019-05-31

NDC 0093-4443-93 [00093444393]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA076017
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-07-11
Marketing End Date2013-09-12

NDC 0093-4443-19 [00093444319]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA076017
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-07-11
Marketing End Date2013-09-12

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN600 mg/1

OpenFDA Data

SPL SET ID:48017784-d2b7-43cc-94bf-5c950d6be263
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310433
  • 310434
  • UPC Code
  • 0300934443011
  • 0300934444018
  • 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

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