FDA.reportPublic FDA data

NDC 80425-0097-01 - 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
80425-0097
Requested NDC
80425-0097-01
Package NDCs from labels
80425-0097-4, 80425-0097-3, 80425-0097-2, 80425-0097-1, 80425-0097-01
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
80425-0097-1Gabapentin30 in 1 BOTTLETABLET, FILM COATED309
80425-0097-2Gabapentin60 in 1 BOTTLETABLET, FILM COATED609
80425-0097-3Gabapentin90 in 1 BOTTLETABLET, FILM COATED909
80425-0097-4Gabapentin120 in 1 BOTTLETABLET, FILM COATED1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0097GABAPENTIN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 4 package rows20250101_b37b1dcc-c7e9-8845-e053-2995a90a089e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0097-1EA - Each80425-0097bc516bde-02fd-4626-8789-3414c5fa6ca812023-04-07
80425-0097-2EA - Each80425-00971441034c-5e3a-4dae-9a75-81bcf929c48112023-04-07
80425-0097-3EA - Each80425-00972c32fc62-3047-4609-928c-cb591042f5e312023-04-07
80425-0097-4EA - Each80425-00973de7d030-b62b-46c2-bea1-70c9c08a334012023-04-07

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 8 of 20 · 393 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINA-S Medication Solutions081fd1de-acaa-4685-a053-4959d77b17e92026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d2026-02-09Warnings, Adverse reactionsExact identifier
application number: ANDA200651
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions2343e3a1-82d0-4c70-a086-a01a0ce81ef32026-02-09Warnings, Adverse reactionsExact identifier
application number: ANDA200651
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions67330eef-c976-4862-b1ae-20f30f43df762026-02-09Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack2e331641-ec26-4d76-b16b-a9863c767afe2026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackcc1998a7-7004-4688-8b5b-525041851d1d2026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GABAPENTINGABAPENTINA-S Medication Solutions4aa69d04-6b32-4764-a48b-ef5313dd95d32026-01-23Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.60b46f6d-efbc-487a-b672-b20df8b44cc42026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GABAPENTINGABAPENTINA-S Medication Solutions43a3ec78-8235-4d46-a343-2f9226745a392026-01-23Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINA-S Medication Solutions685553b0-384e-400b-a8ae-612ceece82612026-01-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINA-S Medication Solutions7ea0b220-edbb-45eb-aeb3-65283f8489a12026-01-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.bff3beea-1f05-4e84-bcd2-d05782acddae2026-01-14Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINDIRECT RX29a70e2d-d3fd-4e32-95dd-7ee721d873882026-01-08Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
gabapentinGABAPENTINCoupler LLC47cd25f6-e123-9aaf-e063-6394a90aeedd2026-01-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABARONEGABAPENTININA Pharmaceutics Inc.0f350a4b-f294-4b98-b69f-3cc789e930ba2026-01-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAjenat Pharmaceuticals LLC02304deb-7b4a-452f-9b1a-64ca0aedbcc22025-12-29Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
gabapentinGABAPENTINNorthwind Health Company, LLC471b2d32-0cbd-aade-e063-6394a90a16962025-12-29Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY3aaf3d6e-c6d5-89f5-e063-6394a90a9b772025-12-29Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINNorthwind Health Company, LLC47214c7c-ba1b-9107-e063-6294a90a54312025-12-29Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBioComp Pharma, Inc.0b3a4009-42f3-c84f-e063-6294a90a80682025-12-17Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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