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 71 of 120 · 2,387 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.0ce53f62-1738-43f4-9a2e-c5dc42a91d092025-05-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy7d3fc163-25f0-2c61-e053-2991aa0a76e92025-05-23Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
unii: 15FIX9V2JP
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
unii: 15FIX9V2JP
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINAmneal Pharmaceuticals LLC772d9e7a-3811-455a-99e6-f2a3d0769b9b2025-05-13Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINAurobindo Pharma Limited1a619a14-0b63-4cba-80e7-474c9a1c90b92025-05-12Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINAurobindo Pharma Limited25cf6c40-a239-4dd0-9cad-28da84d285db2025-05-09Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 15FIX9V2JP
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINProficient Rx LP3c8dca11-78ab-45c1-8bb2-89a41ea5dfa92025-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.41d1ead3-046e-4abf-ae0a-cb126a1f58482025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINActavis Pharma, Inc.5969871e-6c71-4c37-9d63-370718ccc80c2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
unii: 15FIX9V2JP
GABAPENTINGABAPENTINCipla USA Inc.9e4eca9c-6a2c-4ede-a252-1a27094bf5942025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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