NDC 83301-0002-01 - 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
83301-0002
Requested NDC
83301-0002-01
Package NDCs from labels
83301-0002-1, 83301-0002-2, 83301-0002-01
Manufacturer
Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.
Effective date
2025-10-28
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., Ltd.Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.2025-10-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0002-1Gabapentin100 in 1 BOTTLE, PLASTICTABLET, COATED1004
83301-0002-2Gabapentin500 in 1 BOTTLE, PLASTICTABLET, COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0002GABAPENTIN TABLET, COATED [MULLAN PHARMACEUTICAL INC.]3Current NDC, 2 package rows20250223_47a22de2-ec66-45be-8648-89ed3ab6e67e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0002-1EA - Each83301-000295df3f21-585d-48b9-a135-692c213aa9c912025-07-08
83301-0002-2EA - Each83301-00020b13247a-88bd-45e4-a6b0-60f3ac7d2c9312025-07-08

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 83 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91ca-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91c8-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
GabapentinGABAPENTINADVANCED RX OF TENNESSEE, LLCaf73fbd8-9731-e6bf-e053-2995a90af65d2024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc80b8b-da39-6fb9-e053-2a95a90a2d8e2024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb062f12c-a745-76d4-e053-2a95a90a3a1a2024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb33c18ea-554d-3cfb-e053-2a95a90a2dd12024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb37b1dcc-c7e9-8845-e053-2995a90a089e2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc898711b-9a65-1816-e053-2995a90a855e2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCd294f6aa-ed82-90a2-e053-2995a90a28962024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCec1c621b-db2a-1567-e053-2995a90a86952024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc89a68b6-6dc0-4624-e053-2a95a90a687e2024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCbc08e35d-ef5d-1dcd-e053-2a95a90ab5de2024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc859e666-d510-426b-e053-2995a90a9a3c2024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCebf57adf-b066-2959-e053-2a95a90a961c2024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCec1a01fe-5531-21df-e053-2a95a90a05612024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA207057
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCf781d400-7304-5d3e-e053-6294a90ac5722024-12-31Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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