FDA.reportPublic FDA data

NDC 83301-0004-01 - 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
83301-0004
Requested NDC
83301-0004-01
Package NDCs from labels
83301-0004-1, 83301-0004-2, 83301-0004-3, 83301-0004-01
Manufacturer
Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd
Effective date
2025-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., LtdMullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd2025-08-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0004-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE10010
83301-0004-2Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE50010
83301-0004-3Gabapentin1000 in 1 BOTTLE, PLASTICCAPSULE100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0004GABAPENTIN CAPSULE [MULLAN PHARMACEUTICAL INC.]9Current NDC, 3 package rows20250411_74474aa4-4859-42d2-92d8-f23f18b34e04.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0004-1EA - Each83301-000468147702-10bf-45ab-8778-32f3f1b00f3e12024-10-04
83301-0004-2EA - Each83301-00048f01f50a-eb39-445e-a88a-4f1145bc24d112025-07-08
83301-0004-3EA - Each83301-000436e8797a-1182-42cb-aee7-d954f67ee1ce12025-07-08

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 13 of 129 · 2,562 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINMajor Pharmaceuticals999f3685-2eac-467e-bed2-1d0c36aaf0ed2026-05-04Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee2026-05-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.35da078b-0da0-4757-a6c4-a9144c37e8e12026-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.38119f2e-33b3-4c3c-99b7-9335d8d280d42026-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb8b7e045-a7fe-8539-e053-2a95a90a40f82026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINSt Mary's Medical Park Pharmacyde990f96-96bc-406d-e053-2995a90abebb2026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINBryant Ranch Prepack4cb26d6e-7963-4fe5-903e-ab51805450662026-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.100ff86c-56a8-4770-9db3-b9bc6b1bd2f72026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.d22ed424-f365-44ca-8ef9-a08255a90ae82026-04-29Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.e3429322-c442-4146-bb68-bcc3a8d015522026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.2625c0ef-5295-41de-9e81-88001a6cbecc2026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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