FDA.reportPublic FDA data

NDC 80425-0199-01 - 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
80425-0199
Requested NDC
80425-0199-01
Package NDCs from labels
80425-0199-2, 80425-0199-3, 80425-0199-1, 80425-0199-4, 80425-0199-01
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
80425-0199-1Gabapentin30 in 1 BOTTLECAPSULE305
80425-0199-2Gabapentin60 in 1 BOTTLECAPSULE605
80425-0199-3Gabapentin90 in 1 BOTTLECAPSULE905
80425-0199-4Gabapentin120 in 1 BOTTLECAPSULE1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0199GABAPENTIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 4 package rows20250101_ec1c621b-db2a-1567-e053-2995a90a8695.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0199-1EA - Each80425-0199d68dc437-0849-41c2-b17b-257d12f6b61c12023-06-06
80425-0199-2EA - Each80425-019972852c7a-f605-4712-bd72-41cd7fab807812023-06-06
80425-0199-3EA - Each80425-0199d088f4ae-c84a-47de-954a-d5659921b2bf12023-06-06
80425-0199-4EA - Each80425-019923d7cfee-4b7b-41a1-a066-247e8cdd763e12023-06-06

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 10 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINBryant Ranch Prepackbe9a572d-e98a-41c1-83c5-859d9176dd1c2025-10-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackeaf5e41e-8ed3-404e-84e0-392bebdbc0b72025-10-03Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINProficient Rx LPda8438e1-755b-4195-baa7-464f3d9ee5bd2025-10-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack8f982b95-4e84-4e0c-a543-747bc3dd75312025-09-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackd0510d04-460c-47d1-be72-0ee32c4ac6402025-09-26Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack344d67fa-092e-4e71-b96a-25c71bfa6bb12025-09-25Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepackbc1316b6-1fc4-4990-95a8-4898817728762025-09-25Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINKesin Pharma Corporation3f2ba3d6-6086-eaf2-e063-6294a90a76422025-09-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
gabapentinGABAPENTINCoupler LLC3eeda97d-c3cd-65cd-e063-6394a90aae8b2025-09-16Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
gabapentinGABAPENTINZydus Lifesciences Limited8c0eeefc-ef5b-49f4-8411-ddbae312ed052025-09-15Exact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINMARKSANS PHARMA LIMITED98bb408d-c402-4da6-8f9d-5de4833dedc42025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINEpic Pharma, LLCd592d828-8df1-480d-b179-bb9260a9c8242025-09-12Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINZydus Pharmaceuticals USA Inc.310ce005-5a24-489a-b23c-d42ab6a3bfed2025-09-08Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
gabapentinGABAPENTINZydus Pharmaceuticals USA Inc.3cfd04ab-e421-441f-a10e-e4dd1412974d2025-09-05Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINRising Pharma Holdings, Inc.b1a9808d-31a5-4b63-afd0-d96d5a0ad7a12025-09-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINMullan Pharmaceutical Inc.74474aa4-4859-42d2-92d8-f23f18b34e042025-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA075477
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINDirect_Rx2cb1ad6d-d389-4564-e063-6394a90a36442025-08-19Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINBryant Ranch Prepack137b2b9a-9d42-48d0-913f-5dc146fb689a2025-08-19Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.b4c7388a-19d9-4e3a-83c9-4943fb855be42025-08-18Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.9ead7825-d11b-4e00-8533-328d097b8f832025-08-16Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

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