FDA.reportPublic FDA data

NDC 80425-0158-01 - 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
80425-0158
Requested NDC
80425-0158-01
Package NDCs from labels
80425-0158-2, 80425-0158-1, 80425-0158-01
Manufacturer
Advanced Rx Pharmacy 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 Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0158-1Gabapentin30 in 1 BOTTLETABLET, FILM COATED306
80425-0158-2Gabapentin60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0158GABAPENTIN TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_c898711b-9a65-1816-e053-2995a90a855e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0158-1EA - Each80425-015874c494cd-6525-480a-b11c-314dcbed94b712023-04-07
80425-0158-2EA - Each80425-0158a3e5f772-c3d2-4125-94d3-1be32b83dbe812023-04-07

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 9 of 20 · 393 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.b86c81d9-9a4a-4847-be18-520e5cc5dc4b2025-12-12Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINJVET PHARMACEUTICALS LLC63a5fc6d-ca57-4726-b70d-805ac023d9592025-12-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINGlenmark Pharmaceuticals Inc., USA3865a6e3-112c-490c-82ac-35401336b16e2025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINPrecision Dose, Inc.021329d0-7d32-4fd8-81bf-a8b0d8b49e432025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GABAPENTINGABAPENTINRedpharm Drug44f2b497-55b2-864f-e063-6294a90ad6d52025-12-02Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINKesin Pharma Corporation4470a567-93a6-a293-e063-6394a90affc12025-11-25Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutionsb74a427c-9cc1-4b15-9ed2-cc891741fe672025-11-19Warnings, Adverse reactionsExact identifier
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINStrides Pharma Science Limitedbec31452-b52b-4698-ba4c-0b614780ee842025-11-12Warnings, Adverse reactionsExact identifier
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINAcella Pharmaceuticals, LLC3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa22025-11-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack5134369d-c7f6-4569-a425-d50e5a5d694f2025-10-29Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINMullan Pharmaceutical Inc.47a22de2-ec66-45be-8648-89ed3ab6e67e2025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 310433
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions25befbfa-5125-4363-8306-f862e81c0a6f2025-10-28Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackd9d78138-e1e9-4107-9099-4910cb1422d82025-10-22Warnings, Adverse reactionsExact identifier
application number: ANDA200651
rxcui: 310434
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions6e900fc4-a2b3-411f-9ab7-8dcbb97b697b2025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutionsaa246838-609c-4254-a8ec-d6f463a179602025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 310433
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackefb86e22-5a84-4b33-aad0-71dd5a2c6c8f2025-10-13Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions1ead7343-ab25-41b5-af4f-f903470e1dd92025-10-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions781b0d62-a760-4371-8908-1f61329928a62025-10-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINSTALLION LABORATORIES PRIVATE LIMITEDb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92025-10-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINAmerican Health Packagingbbfdedd7-2baf-4bc6-be59-548a5cf217522025-10-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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