FDA.reportPublic FDA data

NDC 68084-797-11 - Gabapentin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-797
Requested NDC
68084-797-11
Package NDCs from labels
68084-797-11, 68084-797-01
Manufacturer
Cardinal Health
Effective date
2021-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - Cardinal HealthCardinal Health2021-04-24HUMAN PRESCRIPTION DRUG LABEL
Gabapentin - American Health PackagingAmerican Health Packaging2020-04-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-797-01EA - Each68084-79723db1bca-9a82-4fbd-b379-a78b9bafd3a712014-12-01
68084-797-11EA - Each68084-79721f03a37-f941-4110-ac96-c4ba8c8e073f12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 24 · 468 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINGranules Pharmaceuticals Incc681c804-c6f3-d63b-e053-2995a90a6b8f2026-06-17Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAsclemed USA, Inc.9a829dc3-b2d8-4d19-a579-0597217cec9b2026-06-17Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackd8604417-9d43-4d27-a7ce-d4120ff201f42026-06-11Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb7a29b99-ce23-950e-e053-2995a90a19342026-06-09Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack4c49d34d-bb47-406b-8f2d-b4834b2ee9d02026-06-08Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINCoupler LLC5385e27c-f2fa-32d5-e063-6294a90a0a8c2026-06-05Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAscend Laboratories, LLC4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a2026-06-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINSt. Mary's Medical Park Pharmacy07f07d15-ee91-8c2a-e063-6394a90a46242026-06-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINCardinal Health 107, LLCb2da7d96-73ad-4f44-8784-160a384a09612026-06-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyf93eaa4f-cc1a-10ab-e053-6394a90a5ffc2026-06-02Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINDirect_Rxf8998c1c-c359-6f01-e053-6294a90aebf42026-06-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
gabapentinGABAPENTINProficient Rx LPc7674ea5-276b-4bb3-821b-4ac05c9e64e62026-06-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAmneal Pharmaceuticals LLC507bf6d0-e7a2-413d-9848-cd2445a1411d2026-05-30Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINLaurus Labs Limited07aa1bcc-df05-44fa-92d4-63894e0e6cd62026-05-28Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions03031adf-d36b-45ec-944e-dfce5a5de91a2026-05-28Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
GABAPENTINGABAPENTINPangea Pharmaceuticals, LLC5eff7ad8-0d31-4372-82a2-ac9f549d87962026-05-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack397fd6d3-317b-4b61-a52b-3a09ca1d88a42026-05-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack13640281-26b4-402e-8f69-7c81cd6e03762026-05-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAmici Pharma, Inc.1ea83c18-7107-41f4-8305-62725c1c45c82026-05-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.