NDC 0440-5563

GABAPENTIN

Gabapentin

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

Product ID0440-5563_29c0c23b-f87d-4a94-a411-4091f399ecd1
NDC0440-5563
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 NameLiberty Pharmaceuticals, Inc.
Substance NameGABAPENTIN
Active Ingredient Strength800 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 0440-5563-05

500 TABLET, FILM COATED in 1 BOTTLE (0440-5563-05)
Marketing Start Date2012-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0440-5563-94 [00440556394]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-02
Inactivation Date2020-01-31

NDC 0440-5563-30 [00440556330]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-02
Inactivation Date2020-01-31

NDC 0440-5563-90 [00440556390]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-02
Inactivation Date2020-01-31

NDC 0440-5563-60 [00440556360]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-02
Inactivation Date2020-01-31

NDC 0440-5563-91 [00440556391]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-02
Inactivation Date2020-01-31

NDC 0440-5563-92 [00440556392]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-02
Inactivation Date2020-01-31

NDC 0440-5563-05 [00440556305]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-02
Inactivation Date2020-01-31

NDC 0440-5563-81 [00440556381]

GABAPENTIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN800 mg/1

OpenFDA Data

SPL SET ID:0002eded-a283-4590-a78c-b6ff2027e684
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310433
  • 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
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