NDC 42192-608

Gabapentin

Gabapentin

Gabapentin is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Acella Pharmaceuticals, Llc. The primary component is Gabapentin.

Product ID42192-608_5b2305df-d46e-6506-e053-2a91aa0a9069
NDC42192-608
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2012-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA076403
Labeler NameAcella Pharmaceuticals, LLC
Substance NameGABAPENTIN
Active Ingredient Strength250 mg/5mL
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42192-608-06

6 mL in 1 CUP, UNIT-DOSE (42192-608-06)
Marketing Start Date2019-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42192-608-06 [42192060806]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA076403
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-16

NDC 42192-608-40 [42192060840]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA076403
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-16

NDC 42192-608-16 [42192060816]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA076403
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-10-01

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN250 mg/5mL

OpenFDA Data

SPL SET ID:3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283523
  • UPC Code
  • 0342192608160
  • Pharmacological Class

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

    Medicade Reported Pricing

    42192060816 GABAPENTIN 250 MG/5 ML SOLN

    Pricing Unit: ML | Drug Type:

    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.