NDC 17856-0311

Gabapentin

Gabapentin

Gabapentin is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Gabapentin.

Product ID17856-0311_a85eb3d4-e7d4-4a52-87fd-5d57e2732175
NDC17856-0311
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-02-23
Marketing CategoryANDA / ANDA
Application NumberANDA078974
Labeler NameAtlantic Biologicals Corps
Substance NameGABAPENTIN
Active Ingredient Strength250 mg/5mL
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0311-3

6 mL in 1 CUP (17856-0311-3)
Marketing Start Date2016-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0311-2 [17856031102]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA078974
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-04
Inactivation Date2020-01-31

NDC 17856-0311-3 [17856031103]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA078974
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN250 mg/5mL

OpenFDA Data

SPL SET ID:31e18a2a-b43f-4b53-a51d-7479781bae7c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283523

    • 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.