NDC 83301-0003-01 - 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
83301-0003
Requested NDC
83301-0003-01
Package NDCs from labels
83301-0003-1, 83301-0003-2, 83301-0003-3, 83301-0003-01
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
83301-0003-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE10010
83301-0003-2Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE50010
83301-0003-3Gabapentin1000 in 1 BOTTLE, PLASTICCAPSULE100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0003GABAPENTIN 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
83301-0003-1EA - Each83301-000348fb29f0-710e-4631-a0ae-f2d137c5ce8012025-07-08
83301-0003-2EA - Each83301-000336eeae7f-ed52-4f55-a41b-deb41187275012025-07-08
83301-0003-3EA - Each83301-00035fdaad8f-bb94-40a7-a1e6-0ca5cb6b74da12024-10-04

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 121 of 127 · 2,533 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC20e48004-d8b6-40fd-929b-b95087b4d85d2022-11-28Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LPc7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC88ac51c4-5fa9-4c35-9c63-f26bcb101d4b2022-10-18Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINAsclemed USA, Inc.e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINAsclemed USA, Inc.9d544944-ea95-42e1-8c65-9e442437f0ee2022-10-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LPf651a143-3f88-49c9-b5c4-c9af55aea76a2022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP176c5b60-93c2-4574-8b51-c15180912aaa2022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
NeurontinGABAPENTINParke-Davis Div of Pfizer Incee9ad9ed-6d9f-4ee1-9d7f-cfad438df3882022-07-12Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINAsclemed USA, Inc.14b1840d-a2db-4eec-bc25-029e35b042e42022-07-09Warnings, Adverse reactionsExact identifier
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINAsclemed USA, Inc.c18d9d06-f796-4eb7-8fd5-1de4ebb954392022-07-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
AddiclenzBETA VULGARIS, BOLDO, 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, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 15FIX9V2JP
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC17988b64-723c-488d-befd-3e4e4cc44bd22022-05-11Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LPed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e2022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP645824d0-eb3d-442b-806d-36a70796cb8e2022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GABAPENTINGABAPENTINProficient Rx LPaa3ab216-372a-4a72-bfd1-88a1ffa31ba32022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LPb67b7865-df64-429a-9550-5333b9c713ea2022-04-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP223a9216-6e07-49b9-8faf-bb4e529a6ae52022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP2fb2233f-9152-4630-ab39-51a0cda7e5ca2022-04-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP52af51ab-6543-466b-848c-13c588c987892022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINProficient Rx LP2b76955c-52a4-4026-b286-3da1112fe9892022-04-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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