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 77 of 120 · 2,387 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Inc5c4219ac-d65f-43a5-8ec4-8732b9b344cf2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Brush and Go Oily Problematic SkinTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdb4295453-f193-4bed-be5b-efcd917721072025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
SUN PROTECT LIP BALM SPF 30ZINC OXIDE AND TITANIUM DIOXIDEStream2Sea, LLC21386652-b952-48be-b077-1acecc7f0eb02025-01-12WarningsExact identifier
unii: 15FIX9V2JP
Dermaroller Anhydrous Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.04e82f1b-c893-4795-b7a9-0523e3ec75522025-01-10WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC41ce952c-6c16-4b5d-adf7-9ea114e63eb32025-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA204989
unii: 6CW7F3G59X
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC13b87441-8fe1-40f5-8ffb-00dcd8cc90a62025-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA204989
unii: 6CW7F3G59X
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENEW SEASON DERMATOLOGY, PLLCfecd72a3-c7e5-3dfa-e053-6394a90a73572025-01-09WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINAvPAKfaa47fcd-2545-a946-e053-6294a90a05d22025-01-09Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
ECLIPSE SPF 50 PERFECTINT BEIGETITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLCb69dda25-372f-15d9-e053-2995a90a8d3e2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
Extreme Protect SPF 40 All ShadesZINC OXIDE, TITANIUM DIOXIDEScience of Skincare, LLC.b69db78b-5f0e-8ca2-e053-2a95a90ac88c2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
ECLIPSE SPF 50 ALL SHADESTITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLC49df51e6-be9a-41be-b3e1-bfc062aaceaa2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC95757436-2093-41cf-a9a9-ef2f28ac096f2025-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA204989
unii: 6CW7F3G59X
CoTZ Mineral Suns Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD44a6ff9b-8067-4f32-acb2-4ede54c79e6e2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
TiZO Tinted Lip Protection SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a22025-01-09WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Face Prime and Protect SPF 40 (Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1088fbf6-5790-490d-b272-ec281b4b76fa2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
unii: 15FIX9V2JP
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEETHEREAL AESTHETICS LLC065d17cf-bea5-137f-e063-6394a90aeeb32025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESERRAO, E JOHN MD FACOGfea61544-6684-ad34-e053-6294a90a48f32025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENew Beginnings Tattoo Removalfea87de3-116f-4774-e053-6394a90a0aad2025-01-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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