FDA.reportPublic FDA data

NDC 83301-0002-01 - 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
83301-0002
Requested NDC
83301-0002-01
Package NDCs from labels
83301-0002-1, 83301-0002-2, 83301-0002-01
Manufacturer
Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.
Effective date
2025-10-28
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., Ltd.Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.2025-10-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0002-1Gabapentin100 in 1 BOTTLE, PLASTICTABLET, COATED1004
83301-0002-2Gabapentin500 in 1 BOTTLE, PLASTICTABLET, COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0002GABAPENTIN TABLET, COATED [MULLAN PHARMACEUTICAL INC.]3Current NDC, 2 package rows20250223_47a22de2-ec66-45be-8648-89ed3ab6e67e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0002-1EA - Each83301-000295df3f21-585d-48b9-a135-692c213aa9c912025-07-08
83301-0002-2EA - Each83301-00020b13247a-88bd-45e4-a6b0-60f3ac7d2c9312025-07-08

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 19 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAdvagen Pharma Ltdbfee67dc-d2b1-4a00-92d9-a42be3189c742026-02-24Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINScieGen Pharmaceuticals, Inc.5ab9c18b-9568-4dcb-90b0-252aef8f8dc22026-02-20Warnings, Adverse reactionsExact identifier
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.9814b76c-87c6-4746-b712-3269352a901b2026-02-16Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d8daa30f-1cb3-46aa-9b68-d9aa5b0a21052026-02-12Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutionsc979f80b-d4b1-40f7-b878-b216db5f325d2026-02-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutionsb88b0cbc-c883-4d17-8f46-0e5bddc578352026-02-10Warnings, Adverse reactionsExact identifier
application number: ANDA207057
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions3dbd447f-4791-4c62-86b4-6f79288627852026-02-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions081fd1de-acaa-4685-a053-4959d77b17e92026-02-10Warnings, Adverse reactionsExact identifier
application number: ANDA207057
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d2026-02-09Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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