NDC 52343-031

Gabapentin

Gabapentin

Gabapentin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Acetris Health, Llc. The primary component is Gabapentin.

Product ID52343-031_19e835f7-2223-4d65-a702-70176cd1c9c7
NDC52343-031
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-01-31
Marketing End Date2020-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA078787
Labeler NameACETRIS HEALTH, LLC
Substance NameGABAPENTIN
Active Ingredient Strength300 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN

Packaging

NDC 52343-031-01

100 CAPSULE in 1 BOTTLE (52343-031-01)
Marketing Start Date2008-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52343-031-99 [52343003199]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Marketing End Date2020-09-01

NDC 52343-031-18 [52343003118]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Marketing End Date2020-09-01

NDC 52343-031-01 [52343003101]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Marketing End Date2020-09-01

NDC 52343-031-27 [52343003127]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Marketing End Date2020-09-01

NDC 52343-031-05 [52343003105]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-01-31
Marketing End Date2018-03-26

NDC 52343-031-30 [52343003130]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Marketing End Date2020-09-01

NDC 52343-031-90 [52343003190]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Marketing End Date2020-09-01

NDC 52343-031-60 [52343003160]

Gabapentin CAPSULE
Marketing CategoryANDA
Application NumberANDA078787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Marketing End Date2020-09-01

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN300 mg/1

OpenFDA Data

SPL SET ID:531ad835-dbad-4252-ab61-561eb00a0359
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310432
  • 310431
  • 310430
    • UPC Code
  • 0352343030016
  • 0352343031013
  • 0352343032010

    • 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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