FDA.reportPublic FDA data

NDC 80425-0030-01 - Pregabalin

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
80425-0030
Requested NDC
80425-0030-01
Package NDCs from labels
80425-0030-2, 80425-0030-1, 80425-0030-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-11-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pregabalin - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-11-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0030-1Pregabalin60 in 1 BOTTLECAPSULE607
80425-0030-2Pregabalin90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0030PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_afc89689-bea9-92ec-e053-2995a90a7f21.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0030-1EA - Each80425-00306d24910f-7f13-4a9b-9add-abcb3d5bf6bf12023-04-07
80425-0030-2EA - Each80425-0030d14237e9-9109-400a-9074-772dc5d6d05712023-04-07

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 5 of 12 · 227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREGABALINPREGABALINREMEDYREPACK INC.1a8f13f6-0f4c-4194-ba37-b2d1a8fc49932026-02-09Warnings, Adverse reactionsExact identifier
rxcui: 577127
unii: 55JG375S6M
PREGABALINPREGABALINA-S Medication Solutions54a9bfb4-dcff-491d-9676-1fe1d05e004c2026-02-08Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINA-S Medication Solutions217c9f93-fe89-4684-8553-12ec9acaa5072026-02-08Warnings, Adverse reactionsExact identifier
application number: ANDA209357
rxcui: 483438
unii: 55JG375S6M
PregabalinPREGABALINA-S Medication Solutions5d33e9c7-6d81-485b-bf4a-9a588eda52082026-02-08Warnings, Adverse reactionsExact identifier
application number: ANDA209357
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINA-S Medication Solutionsfa24fa02-e27d-476a-b6c4-93650aaaee682026-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA209357
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINA-S Medication Solutions55b62778-0e6a-45e8-9ace-3f1d6eca44872026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC99c3d252-4d51-4679-aa61-e2d0b8238b382026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PregabalinPREGABALINAdvagen Pharma Ltd.2ffee7e7-bfa0-4933-9baf-7df55080816e2026-02-04Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINCoupler LLC463d31dd-ff14-cc89-e063-6294a90a2ea92026-01-15Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PREGABALINPREGABALINMajor Pharmaceuticals2420e2d7-c01a-4590-88c5-6fe5361747e92026-01-06Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PREGABALINPREGABALINEskayef Pharmaceuticals Limited65d9e751-61c2-4741-85c0-2526cfdc765c2025-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PREGABALIN capsules, CVPREGABALIN CAPSULES, CVCipla USA Inc.7d93359c-1849-430d-a922-21d42932d0f32025-12-22Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINAscend Laboratories, LLC1b731dd5-b000-4c38-bfc8-2505b076e3162025-12-22Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINGolden State Medical Supply, Inc.1ef735e8-467e-ed0d-e063-6294a90a210e2025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINNorthStar RxLLC4a4d4c76-31c5-413b-be7c-82cb8091c19d2025-12-12Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINScieGen Pharmaceuticals, Inc459f0d31-a73f-2c62-e063-6394a90a810c2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc89689-bea9-92ec-e053-2995a90a7f212025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA209357
ndc (package): 80425-0030-2
ndc (package): 80425-0030-1
ndc (product): 80425-0030
ndc11 (package): 80425003001
rxcui: 483450
spl id: 43ccc5cb-7aee-4ee0-e063-6294a90af140
spl set id: afc89689-bea9-92ec-e053-2995a90a7f21
unii: 55JG375S6M
PregabalinPREGABALINChartwell RX, LLC13d03119-e49b-482e-b5f9-d40dc3f4862e2025-11-12Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483448
rxcui: 483438
rxcui: 483450
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepack335e3bcb-10a3-481b-ad95-ee9ceaa3689e2025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PregabalinPREGABALINWestminster Pharmaceuticals, LLC6b0ee2cf-52c3-4052-bea0-1458a42337452025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

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