NDC 33261-116

Gabapentin

Gabapentin

Gabapentin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Gabapentin.

Product ID33261-116_0756b645-0741-4473-b777-7ee472358140
NDC33261-116
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-10-06
Marketing CategoryANDA / ANDA
Application NumberANDA200651
Labeler NameAidarex Pharmaceuticals LLC
Substance NameGABAPENTIN
Active Ingredient Strength800 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 33261-116-21

21 TABLET, FILM COATED in 1 BOTTLE (33261-116-21)
Marketing Start Date2011-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-116-20 [33261011620]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-97 [33261011697]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-60 [33261011660]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-45 [33261011645]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-99 [33261011699]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-00 [33261011600]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-02 [33261011602]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-81 [33261011681]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-21 [33261011621]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-42 [33261011642]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-90 [33261011690]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-10 [33261011610]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

NDC 33261-116-30 [33261011630]

Gabapentin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200651
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-06
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN800 mg/1

OpenFDA Data

SPL SET ID:41f1e929-7c1f-4b3e-b142-4b7533300ee2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310433
  • 310434

    • 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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