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 58 of 129 · 2,562 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
unii: 15FIX9V2JP
Healthy Mineral Sunscreen No Shine - No TintTITANIUM DIOXIDE, ZINC OXIDEZen Dermatology, Inc.31572a16-5f60-565f-e063-6394a90ab8c92025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.315894b7-ac1b-0982-e063-6294a90ab8792025-12-08Exact identifier
unii: 15FIX9V2JP
Shunly Natural Cover SPF50TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Carea64e373b-b3f6-4024-b5f5-253783485cd62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.31583c7e-365a-d899-e063-6394a90aa63f2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334ec844-5560-50f7-e063-6394a90a01be2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334f90d6-68e5-db37-e063-6294a90a5fb12025-12-08Exact identifier
unii: 15FIX9V2JP
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c44baf4-9555-faad-e063-6294a90ab24f2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Bare Barrier SportTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c580794-eda3-de57-e063-6294a90a03032025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Flawless Brightening SunscreenTITANIUM DIOXIDE, ZINC OXIDEFlawless Skin Care LLC312e9ca0-a388-a546-e063-6294a90a15d62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, protectTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2f8859cf-8277-6ea9-e063-6294a90a1a752025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb19ed7-8cee-ce80-e063-6394a90ad3dc2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb14c4f-a435-aa6e-e063-6394a90a7d8d2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF 40 Non-TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc4f701-eea2-7913-e063-6294a90a86932025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc55e8c-41d6-15cc-e063-6394a90ac5432025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Daily Tinted Mineral SPFTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc6e168-b2c1-bf9d-e063-6394a90aade72025-12-08WarningsExact identifier
unii: 15FIX9V2JP
UV Shade tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b3a1e-8410-da06-e063-6294a90a462f2025-12-08Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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