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 2 of 24 · 468 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINBryant Ranch Prepack8a781649-3271-47a6-995f-50f91141a48a2026-08-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack6670a64f-7f58-479f-b285-394abb753e2e2026-08-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINCoupler LLC5954a330-c225-00bd-e063-6294a90a75812026-08-18Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
GabapentinGABAPENTINTrifluent Pharma, LLC59442de1-7cf0-35f6-e063-6294a90a57d72026-08-17Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackcb81fd89-b32b-4538-bf5c-ab02f65b34582026-08-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack691205ba-fa65-4bc9-ba20-7d361382cff92026-08-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack97e47698-97c9-4eb5-a108-5850c2aa28182026-08-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack2ac0622c-440a-49a0-974f-726e6ac72a0e2026-08-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack48037fc4-1aab-4ae8-aede-7c55b494877a2026-08-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.ddb3a54f-5224-4024-8804-b2a2f01d885e2026-08-06Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.fce0c123-29d7-42bf-8c8d-8be1772e2d992026-08-06Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINCoupler LLC583ab038-7b6e-96f8-e063-6294a90adf472026-08-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINTIME CAP LABORATORIES, INC08880902-bd44-41b6-866b-2cbad4c3f2b12026-07-30Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.81243958-cc5a-4ec0-a64d-71682f949d5f2026-07-30Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.bc525ae4-9843-4038-a1b7-0d3543e2282c2026-07-30Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINCardinal Health 107, LLC41844c21-9e2a-4332-a8ff-9b71ae9032b02026-07-30Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINTAGI Pharma, Inc.725878fa-1e2f-4fee-a9e1-a6e102c796252026-07-28Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAscend Laboratories, LLC722de2a9-38b3-4518-b262-ba0d1346d0ba2026-07-24Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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