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 2 of 130 · 2,585 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINREMEDYREPACK INC.d06380d0-c894-427e-b13e-5a8f9eb86a342026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.7652adc6-1aad-4422-b85c-0c6b11c23b732026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINBryant Ranch Prepackf0e7a6c9-ae6c-4259-81ab-a37db54e3c802026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
gabapentinGABAPENTINNuCare Pharmaceuticals, Inc.596eb696-7696-202e-e063-6394a90a28442026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackeb2f6784-e7be-41b6-871b-2c3c961664ab2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack8a781649-3271-47a6-995f-50f91141a48a2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack6670a64f-7f58-479f-b285-394abb753e2e2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINCoupler LLC5954a330-c225-00bd-e063-6294a90a75812026-08-18Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINTrifluent Pharma, LLC59442de1-7cf0-35f6-e063-6294a90a57d72026-08-17Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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