NDC 45865-498

Gabapentin

Gabapentin

Gabapentin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Gabapentin.

Product ID45865-498_1e3d9001-2d0b-2c2e-e054-00144ff8d46c
NDC45865-498
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA090705
Labeler NameMedsource Pharmaceuticals
Substance NameGABAPENTIN
Active Ingredient Strength400 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 45865-498-30

30 CAPSULE in 1 BOTTLE (45865-498-30)
Marketing Start Date2015-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-498-60 [45865049860]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-26

NDC 45865-498-90 [45865049890]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-26

NDC 45865-498-30 [45865049830]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA090705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-26

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN400 mg/1

OpenFDA Data

SPL SET ID:1e3d9001-2d0a-2c2e-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310432

    • 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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