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 126 of 127 · 2,533 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC6702ed8f-4aaf-46fa-bf39-db75154aa44c2018-10-19Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC1b73e9db-eddb-49ba-9778-01d39ece4d162018-09-21Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCf455b415-12a2-4916-b826-246976a8af442018-09-12Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC5fbd601f-df95-4a79-a7d3-c3505e23b9132018-09-06Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 15FIX9V2JP
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC9d1b9121-c25a-4d28-91c5-5fc72f1167f42018-07-12Exact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC37d4d465-19a5-46db-80dc-0b7334b3343a2018-06-25Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC6fc8e8b2-5d0e-4c72-9a46-6d312c3efac72018-05-14Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20Mana Products657d5090-30a8-46d0-879d-469178aa234d2018-01-25WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Moisturizer Broad Spectrum SPF 20ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc316c2132-ab81-47f6-8e80-71e9252a26632017-12-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc96d2d0f1-dbde-4b66-9b2c-9d07f75470662017-12-11WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 IvoryZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incfe207b88-8eb8-424d-89b4-8d5b188dd2c32017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TawnyZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc94d604d4-b0bf-4f3e-888c-b6104241925b2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CocoaZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc9f6a5740-174c-4244-b291-6ab6367ce5122017-12-05WarningsExact identifier
unii: 15FIX9V2JP
SkinPerfect Primer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEDermalogica, Inc.5fc75cef-5b76-44ab-891a-7b90c04a06812017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TaupeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc46e1dc9c-acb8-4a61-8503-065d18c9eb302017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CreamZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc5096ab46-879c-49ec-b0f0-18462814adec2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 Warm BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incd8cab2e9-02fd-451c-b0e0-70ba0fc274d52017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 SandZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Ince5e8d83e-b3e6-470f-b521-4d7e96ecd1b62017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incec6749b7-377b-4ac5-8992-ac709bd0204e2017-12-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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