NDC 50383-311

Gabapentin

Gabapentin

Gabapentin is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Gabapentin.

Product ID50383-311_285fe05b-1b78-46c7-8c79-bef8f0b43b56
NDC50383-311
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-02-23
Marketing CategoryANDA / ANDA
Application NumberANDA078974
Labeler NameHi-Tech Pharmacal Co., Inc.
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 Through2020-12-31

Packaging

NDC 50383-311-07

4 TRAY in 1 CASE (50383-311-07) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-311-05)
Marketing Start Date2015-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-311-05 [50383031105]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA078974
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-08-27

NDC 50383-311-07 [50383031107]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA078974
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-22

NDC 50383-311-47 [50383031147]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA078974
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-02-23

NDC 50383-311-06 [50383031106]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA078974
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-08-27

NDC 50383-311-09 [50383031109]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA078974
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-22

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN250 mg/5mL

OpenFDA Data

SPL SET ID:c64c09c9-0567-4a4f-b2c6-8f667986c9af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283523

    • Pharmacological Class

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

    Medicade Reported Pricing

    50383031147 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
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