FDA.reportPublic FDA data

NDC 83301-0004-03 - 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
83301-0004-03
Package NDCs from labels
83301-0004-1, 83301-0004-2, 83301-0004-3, 83301-0004-03
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 76 of 127 · 2,533 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 310432
rxcui: 310431
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
unii: 1K09F3G675
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
application number: ANDA075477
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.41d1ead3-046e-4abf-ae0a-cb126a1f58482025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINActavis Pharma, Inc.5969871e-6c71-4c37-9d63-370718ccc80c2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
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
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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