FDA.reportPublic FDA data

NDC 80425-0029-01 - 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
80425-0029
Requested NDC
80425-0029-01
Package NDCs from labels
80425-0029-2, 80425-0029-1, 80425-0029-3, 80425-0029-01
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
Pregabalin - 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
80425-0029-1Pregabalin60 in 1 BOTTLECAPSULE607
80425-0029-2Pregabalin90 in 1 BOTTLECAPSULE907
80425-0029-3Pregabalin30 in 1 BOTTLECAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0029PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_afc89ca3-5597-1c75-e053-2a95a90a3ff2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0029-1EA - Each80425-00290511c5d5-7ea6-4a47-8714-e802f6cb8c7012023-04-07
80425-0029-2EA - Each80425-0029b4269445-5768-4e24-974e-62210b5bfebc12023-04-07
80425-0029-3EA - Each80425-00293d5cd76c-f0f1-4d7a-bb72-89f4ad3b073612023-04-07

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 12 · 227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pregabalinPREGABALINDr.Reddys Laboratories Incceed457b-8f43-4021-fd70-071c96e094702025-05-20Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregablinPREGABLINMacleods Pharmaceuticals Limiteda3a94949-3060-4057-9b29-e06a808cbd762025-05-14Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINCipla USA, Inc.17a8087c-579f-42de-ae92-006ea64def2a2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINExelan Pharmaceuticals Inc.3fdc6e94-2504-416c-81dd-2db9bc194ebb2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
LyricaPREGABALINViatris Specialty LLCd4734e7d-5079-455e-8ff5-8f4539c998a92025-04-15Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINMylan Pharmaceuticals Inc.ebe34db4-816d-4f0a-adbb-8266936627542025-04-12Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCb1f4b888-ac88-4250-8db1-706e7cc01e932025-03-21Warnings, Adverse reactionsExact identifier
rxcui: 483444
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCb0f34220-0657-4868-ae01-014f9300f6222025-03-03Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP580955ba-86f6-4e86-b0fa-dd44e8828b0e2025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LPa025e4fc-e0c1-4c5b-a1c8-bd8e578a737e2025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINCoupler LLC2ccc641e-6859-046e-e063-6294a90a50172025-01-28Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PREGABALINPREGABALINDirect_Rx8efb9652-86b9-4cb5-e053-2995a90adac02025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PREGABALINPREGABALINDirect_Rx8ee9e08f-cf87-599c-e053-2995a90a563c2025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PREGABALINPREGABALINDirect Rxd88925b8-9be6-d862-e053-2995a90a16122025-01-21Adverse reactionsExact identifier
rxcui: 577127
unii: 55JG375S6M
PREGABALINPREGABALINDirect_Rx91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d2025-01-17Warnings, Adverse reactionsExact identifier
application number: ANDA209743
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483438
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.8c3aedae-9745-4f63-ad64-a643f02454182025-01-16Warnings, Adverse reactionsExact identifier
rxcui: 483444
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP2b87989d-6411-4996-8f05-05806ab805252025-01-01Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc89ca3-5597-1c75-e053-2a95a90a3ff22024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA209743
ndc (package): 80425-0029-3
ndc (package): 80425-0029-2
ndc (package): 80425-0029-1
ndc (product): 80425-0029
ndc11 (package): 80425002901
rxcui: 483450
spl id: 2a984dd9-7294-77f0-e063-6294a90a8f1e
spl set id: afc89ca3-5597-1c75-e053-2a95a90a3ff2
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafd59273-75d1-5f33-e053-2995a90ab25f2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc8d9f1-df31-607b-e053-2995a90a028c2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

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