NDC 10544-447

Gabapentin

Gabapentin

Gabapentin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Gabapentin.

Product ID10544-447_a58e76e8-0645-4c40-a738-5015e88bd68c
NDC10544-447
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2014-04-04
Marketing CategoryANDA / ANDA
Application NumberANDA075360
Labeler NameBlenheim Pharmacal, Inc.
Substance NameGABAPENTIN
Active Ingredient Strength400 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-447-84

84 CAPSULE in 1 BOTTLE (10544-447-84)
Marketing Start Date2014-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-447-30 [10544044730]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-04
Inactivation Date2019-11-27

NDC 10544-447-02 [10544044702]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-04
Inactivation Date2019-11-27

NDC 10544-447-60 [10544044760]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-04
Inactivation Date2019-11-27

NDC 10544-447-84 [10544044784]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-04
Inactivation Date2019-11-27

NDC 10544-447-90 [10544044790]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA075360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-04
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN400 mg/1

OpenFDA Data

SPL SET ID:2550a291-51f6-473f-89cd-193bbe97662a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310432
  • 310431
  • 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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