NDC 55289-959

Gabapentin

Gabapentin

Gabapentin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Gabapentin.

Product ID55289-959_7c34cbf2-9ab7-fb86-e053-2a91aa0a9054
NDC55289-959
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2006-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA077662
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameGABAPENTIN
Active Ingredient Strength600 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 55289-959-30

30 TABLET in 1 BOTTLE, PLASTIC (55289-959-30)
Marketing Start Date2020-01-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-959-98 [55289095998]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA077662
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-10

NDC 55289-959-30 [55289095930]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA077662
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-27

NDC 55289-959-90 [55289095990]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA077662
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-10

NDC 55289-959-60 [55289095960]

Gabapentin TABLET
Marketing CategoryANDA
Application NumberANDA077662
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-10

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN600 mg/1

OpenFDA Data

SPL SET ID:7c3b232a-3e9f-4249-9e5a-295482ee288a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310433
    • UPC Code
  • 0355289959984

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.