FDA.reportPublic FDA data

NDC 68084-802-11 - 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
68084-802
Requested NDC
68084-802-11
Package NDCs from labels
68084-802-11, 68084-802-01
Manufacturer
American Health Packaging
Effective date
2020-04-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
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
68084-802-01EA - Each68084-8027ff01dd9-8e30-4962-be65-4ac41e044eb012014-10-03
68084-802-11EA - Each68084-802423b269b-93d6-4f36-bac2-463b98491d3512014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]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 7 of 24 · 467 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCoupler LLC5073abda-321f-29d1-e063-6394a90a59ac2026-04-27Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBluePoint Laboratories3368bf70-d466-4765-b2b7-7fe967a8c2b72026-04-24Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINCoupler LLC500ee820-0378-6fc9-e063-6394a90a109c2026-04-24Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.dd0e12c2-1986-4ca3-a809-d703a75424192026-04-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
GabapentinGABAPENTINPHOENIX RX LLC4f95c01f-200e-bfd7-e063-6394a90abc382026-04-16Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackce0f0d7f-da6d-47da-a4ed-fb8f729024122026-04-13Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackabb56036-88df-4720-ba78-5299716715452026-04-13Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepacka75c9157-a1fc-44cc-89f8-c5a3742fb9ed2026-04-13Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackd1aa4690-57b5-4a3e-ac12-85f777dbd05e2026-04-13Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
RELGAABIGABAPENTINMethod Pharmaceuticals, LLC4cc6615b-5447-9c0e-e063-6394a90a28832026-04-08Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack632cb507-5675-2392-0460-b09c0dd146502026-04-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINStrides Pharma Science Limited798575b9-ddfa-4915-9574-626abbaf025f2026-04-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack75caca13-1432-4c0d-8d45-f029b0b2d4172026-03-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack56378630-e7a7-4981-8212-8ea703a433d82026-03-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY4ddc1342-5c83-f562-e063-6294a90a29ba2026-03-25Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc83432-8fce-6d2a-e053-2a95a90ae73f2026-03-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.81774da8-cb1d-4c7d-8550-35396850d5ff2026-03-18Warnings, Adverse reactionsExact identifier
application number: ANDA078926
unii: 6CW7F3G59X
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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