NDC 43353-863

Gabapentin

Gabapentin

Gabapentin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Gabapentin.

Product ID43353-863_19801231-00a9-4772-b3b1-9be1ac7c1b86
NDC43353-863
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA078787
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameGABAPENTIN
Active Ingredient Strength300 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-863-30

30 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-30)
Marketing Start Date2013-12-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-863-94 [43353086394]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-23

NDC 43353-863-53 [43353086353]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-01

NDC 43353-863-30 [43353086330]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-26

NDC 43353-863-60 [43353086360]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-06

NDC 43353-863-70 [43353086370]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-16

NDC 43353-863-92 [43353086392]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-27

NDC 43353-863-98 [43353086398]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-23

NDC 43353-863-80 [43353086380]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-01

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN300 mg/1

OpenFDA Data

SPL SET ID:f041f43e-dbd8-4cbf-ad77-f0d9c6b8ffa8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310432
  • 310431
  • 310430

    • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • 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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