FDA.reportPublic FDA data

NDC 80425-0079-01 - 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
80425-0079
Requested NDC
80425-0079-01
Package NDCs from labels
80425-0079-3, 80425-0079-2, 80425-0079-1, 80425-0079-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0079-1Gabapentin30 in 1 BOTTLECAPSULE308
80425-0079-2Gabapentin60 in 1 BOTTLECAPSULE608
80425-0079-3Gabapentin90 in 1 BOTTLECAPSULE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0079GABAPENTIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20250101_b062f12c-a745-76d4-e053-2a95a90a3a1a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0079-1EA - Each80425-0079156e411b-e1f2-4460-9cc5-9b0f2f9cf3c512023-06-06
80425-0079-2EA - Each80425-0079a05e3189-5a5e-4124-9eb3-b10aaf17fddc12023-06-06
80425-0079-3EA - Each80425-0079a5cc297e-b491-4928-a738-424fd4df2c7a12023-06-06

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 2 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINTrifluent Pharma, LLC59442de1-7cf0-35f6-e063-6294a90a57d72026-08-17Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackcb81fd89-b32b-4538-bf5c-ab02f65b34582026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack691205ba-fa65-4bc9-ba20-7d361382cff92026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack97e47698-97c9-4eb5-a108-5850c2aa28182026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack2ac0622c-440a-49a0-974f-726e6ac72a0e2026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack48037fc4-1aab-4ae8-aede-7c55b494877a2026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.ddb3a54f-5224-4024-8804-b2a2f01d885e2026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.fce0c123-29d7-42bf-8c8d-8be1772e2d992026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINCoupler LLC583ab038-7b6e-96f8-e063-6294a90adf472026-08-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINTIME CAP LABORATORIES, INC08880902-bd44-41b6-866b-2cbad4c3f2b12026-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA090007
ndc (product): 49483-606
rxcui: 310430
rxcui: 310432
rxcui: 310431
spl id: 57cd7abd-de87-d483-e063-6394a90a90d3
spl set id: 08880902-bd44-41b6-866b-2cbad4c3f2b1
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.81243958-cc5a-4ec0-a64d-71682f949d5f2026-07-30Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.bc525ae4-9843-4038-a1b7-0d3543e2282c2026-07-30Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINCardinal Health 107, LLC41844c21-9e2a-4332-a8ff-9b71ae9032b02026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINTAGI Pharma, Inc.725878fa-1e2f-4fee-a9e1-a6e102c796252026-07-28Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAscend Laboratories, LLC722de2a9-38b3-4518-b262-ba0d1346d0ba2026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINREMEDYREPACK INC.5a78ab50-993d-4857-be10-be665e02b3532026-07-23Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINNuCare Pharmaceuticals, Inc.57383d2a-d2c7-bbdc-e063-6294a90ada982026-07-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINScieGen Pharmaceuticals, Inc.16542ee6-0e0e-4d3c-8b32-60ff6ef488462026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
gabapentinGABAPENTINREMEDYREPACK INC.32169228-e85c-4dbf-8722-cd2f8e0f5d1a2026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a2026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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