FDA.reportPublic FDA data

NDC 80425-0185-01 - 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
80425-0185
Requested NDC
80425-0185-01
Package NDCs from labels
80425-0185-3, 80425-0185-2, 80425-0185-1, 80425-0185-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-11-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PREGABALIN - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-11-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0185-1PREGABALIN30 in 1 BOTTLECAPSULE307
80425-0185-2PREGABALIN60 in 1 BOTTLECAPSULE607
80425-0185-3PREGABALIN90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0185PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20241123_d2813712-d7f6-6144-e053-2995a90a3c5d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0185-1EA - Each80425-01853270f391-a2ec-4234-98e0-d8c13c5e22b212023-06-06
80425-0185-2EA - Each80425-01855620b3dd-776c-4ee1-92f2-73b7f26c6d9112023-04-07
80425-0185-3EA - Each80425-0185834c3e53-a203-4dd9-898a-20b7bd89e8bd12023-04-07

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 11 of 12 · 227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINSun Pharmaceutical Industries, Inc.ee7b9119-e88f-48ad-ae97-55e53374e62f2023-12-21Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP38e80423-0194-4064-9447-abfd29fce1da2023-12-01Warnings, Adverse reactionsExact identifier
rxcui: 483442
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCd2a98872-1a52-47e1-b4bd-0ff7d6272a922023-12-01Warnings, Adverse reactionsExact identifier
rxcui: 577127
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC27d02970-5f8b-4f4f-b89e-e42cc78ddaa32023-11-28Warnings, Adverse reactionsExact identifier
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP137ffe30-ff8b-409d-a719-6be19d4d95222023-10-01Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LPa17f03ea-9375-48fe-be32-f8df509f5fba2023-06-01Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINAlembic Pharmaceuticals Limited78a36538-701d-4dd9-a7fc-87d505784c832023-05-12Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP1d76c6a3-7899-4dec-afcc-2b575dfa6c252023-02-01Warnings, Adverse reactionsExact identifier
rxcui: 483442
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP920c57e0-ddfe-4750-b353-5f96b65443cf2023-01-01Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PregabalinPREGABALINTris Pharma Inc62aa850d-199c-44d5-a730-45f43efa850e2022-11-30Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCdf80e09f-3d57-47a0-ba58-bb79e9ba19532022-11-29Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINAsclemed USA, Inc.3d2464fb-b3ac-496e-b8a5-c2e8a902ce292022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
Pregabalin Extended ReleasePREGABALINScieGen Pharmaceuticals, INC.1544a657-353c-47f8-96ac-a63fa78373f02022-09-19Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP65311ae9-e440-4650-b1b1-6f4495fda93c2022-09-01Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LPc7986739-3fc9-4a1d-8dd6-2e11cf1f36102022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP68829d7b-ab40-429e-92dc-91f8a0d49afd2022-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA207799
rxcui: 483440
unii: 55JG375S6M
PREGABALINPREGABALINPatrin Pharma, Inc.d92c94e5-e542-4177-afa8-fa00ba17634c2022-06-21Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b2022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LPa1545bbb-b337-4760-ab4c-fb76ab0193372022-05-02Warnings, Adverse reactionsExact identifier
application number: ANDA207799
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP1503dd3b-688b-4702-8fc1-954b5ffe42352022-05-02Warnings, Adverse reactionsExact identifier
application number: ANDA207799
rxcui: 483438
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

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