FDA.reportPublic FDA data

NDC 68788-8563-01 - 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
68788-8563
Requested NDC
68788-8563-01
Package NDCs from labels
68788-8563-3, 68788-8563-6, 68788-8563-9, 68788-8563-1, 68788-8563-8, 68788-8563-01
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2026-04-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8563-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1003
68788-8563-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE303
68788-8563-6Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE603
68788-8563-8Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1203
68788-8563-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8563GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240206_2625c0ef-5295-41de-9e81-88001a6cbecc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8563-1EA - Each68788-85632d1f267e-3ef0-40a5-909c-b3d4c50e286212024-05-16
68788-8563-3EA - Each68788-8563b1437b10-b861-44f9-978a-5bc2b13193f312024-05-16
68788-8563-6EA - Each68788-8563202d078f-b330-4a18-a7dd-a3b5820525eb12024-05-16
68788-8563-8EA - Each68788-856390fccd51-866b-40bb-bb13-63eabd8c807212024-05-16
68788-8563-9EA - Each68788-856347068409-e4a7-4d55-bb57-f3418778c8ca12024-05-16

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 3 of 121 · 2,417 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINBryant Ranch Prepack48037fc4-1aab-4ae8-aede-7c55b494877a2026-08-07Warnings, Adverse reactionsExact identifier
application number: ANDA204989
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.ddb3a54f-5224-4024-8804-b2a2f01d885e2026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.fce0c123-29d7-42bf-8c8d-8be1772e2d992026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINCoupler LLC583ab038-7b6e-96f8-e063-6294a90adf472026-08-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
GABAPENTINGABAPENTINTIME CAP LABORATORIES, INC08880902-bd44-41b6-866b-2cbad4c3f2b12026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
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
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINTAGI Pharma, Inc.725878fa-1e2f-4fee-a9e1-a6e102c796252026-07-28Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINAscend Laboratories, LLC722de2a9-38b3-4518-b262-ba0d1346d0ba2026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.5a78ab50-993d-4857-be10-be665e02b3532026-07-23Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINNuCare Pharmaceuticals, Inc.57383d2a-d2c7-bbdc-e063-6294a90ada982026-07-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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