NDC 60505-2548

Gabapentin

Gabapentin

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

Product ID60505-2548_7ce1e8e4-911a-c769-89bb-bb4ab04904b0
NDC60505-2548
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA077894
Labeler NameApotex Corp.
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 60505-2548-8

1000 TABLET, FILM COATED in 1 BOTTLE (60505-2548-8)
Marketing Start Date2006-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-2548-8 [60505254808]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077894
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-10
Marketing End Date2020-01-29

NDC 60505-2548-3 [60505254803]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077894
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-10
Marketing End Date2020-01-29

NDC 60505-2548-1 [60505254801]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077894
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-10
Marketing End Date2020-01-29

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN100 mg/1

OpenFDA Data

SPL SET ID:df12230c-09ea-b03b-c32e-800390ce3e33
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310433
  • 310432
  • 310431
  • 310430
  • 476679
  • 310434
  • 476677
  • 476673
  • UPC Code
  • 0360505254934
  • 0360505011414
  • 0360505011315
  • 0360505255030
  • 0360505254835
  • 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

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