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 66 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINZydus Lifesciences Limited8c0eeefc-ef5b-49f4-8411-ddbae312ed052025-09-15Exact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINMARKSANS PHARMA LIMITED98bb408d-c402-4da6-8f9d-5de4833dedc42025-09-12Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: 532B59J990
GabapentinGABAPENTINEpic Pharma, LLCd592d828-8df1-480d-b179-bb9260a9c8242025-09-12Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
sunscreenTITANIUM DIOXIDE(NANO)Mingyu (guangdong) Cosmetics Technology Co., Ltd3e6fe9f3-486b-bba7-e063-6294a90adf372025-09-10WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINZydus Pharmaceuticals USA Inc.310ce005-5a24-489a-b23c-d42ab6a3bfed2025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 15FIX9V2JP
gabapentinGABAPENTINZydus Pharmaceuticals USA Inc.3cfd04ab-e421-441f-a10e-e4dd1412974d2025-09-05Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.18130858-429c-4ed4-a75b-5bc0144812502025-09-04WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINRising Pharma Holdings, Inc.b1a9808d-31a5-4b63-afd0-d96d5a0ad7a12025-09-03Warnings, Adverse reactionsExact identifier
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
Dolce and Gabbana Everlast Foundation SPF 20 38C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L0358a87d-8002-4f3e-851a-3a582d356edf2025-09-03WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 39N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L34dfc4c5-44f7-4531-97ba-8846ebe147242025-09-03WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
unii: 15FIX9V2JP
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
unii: 15FIX9V2JP
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dba1360-f70f-e450-e063-6394a90a8c9f2025-09-01WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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