NDC 17856-0600

Gabapentin

Gabapentin

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

Product ID17856-0600_813a0f00-fe64-48f4-b3a1-7387ea8c172f
NDC17856-0600
Product TypeHuman Prescription Drug
Proprietary NameGabapentin
Generic NameGabapentin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-06-29
Marketing CategoryANDA / ANDA
Application NumberANDA076403
Labeler NameATLANTIC BIOLOGICALS CORP.
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 Through2021-12-31

Packaging

NDC 17856-0600-1

72 CUP, UNIT-DOSE in 1 BOX (17856-0600-1) > 5 mL in 1 CUP, UNIT-DOSE (17856-0600-4)
Marketing Start Date2020-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0600-2 [17856060002]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA076403
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18
Inactivation Date2020-01-31
Reactivation Date2020-02-18

NDC 17856-0600-1 [17856060001]

Gabapentin SOLUTION
Marketing CategoryANDA
Application NumberANDA076403
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18
Inactivation Date2020-01-31
Reactivation Date2020-02-18

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN250 mg/5mL

OpenFDA Data

SPL SET ID:5969f1a8-d6d5-4967-add5-4e2492354d7b
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
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