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FDA Approval

Gabapentin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
June 16, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Gabapentin(300 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Gabapentin

Product Details

NDC Product Code
68071-2308
Application Number
ANDA204989
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 16, 2022
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
Code: 6CW7F3G59XClass: ACTIBQuantity: 300 mg in 1 1
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