FDA.reportPublic FDA data

NDC 59762-1576-01 - 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
59762-1576
Requested NDC
59762-1576-01
Package NDCs from labels
59762-1576-1, 59762-1576-01
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2025-04-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pregabalin - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2025-04-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1576-1Pregabalin473 mL in 1 BOTTLESOLUTION47313
59762-1576-1Pregabalin1 in 1 CARTONSOLUTION113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1576PREGABALIN CAPSULE PREGABALIN SOLUTION [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 2 package rows20250503_ebe34db4-816d-4f0a-adbb-826693662754.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1576-1ML - Milliliter59762-1576df09e3dc-a25b-4f2e-abaf-f9c3d23a3cc212019-08-06

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 9 of 21 · 412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC14c00449-c3b8-d6ba-e063-6294a90ab6272025-10-27Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINScieGen Pharmaceuticals, Inc33ef1a3b-554f-4a51-afdb-92a019e8c16c2025-10-15Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PREGABALINPREGABALINCreekwood Pharmaceuticals LLCbfe4108e-b2d2-4059-be16-21d3276c3ae42025-10-09Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAvPAK40c0f658-2a0a-034b-e063-6394a90a10972025-10-09Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCbf710bcf-75ed-4184-b9c3-81cd05a780a42025-10-09Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepackb5b22ec1-3fd8-4631-ba7e-98d8e5d030b32025-10-02Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINWestminster Pharmaceuticals, LLC781cb1ac-a0d2-4b47-b319-f0b90de863842025-10-01Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP7d25bec8-b503-4f63-8995-372a6df58c722025-10-01Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepack3ce4dfdf-e32f-40e8-9a13-e45d51539e082025-09-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINCamber Pharmaceuticals, Inc.241c4b7e-f719-4828-8639-ea613b8a65832025-09-29Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
PREGABALINPREGABALINBryant Ranch Prepackca861bfb-caef-4764-bad5-c95a0d0354752025-09-23Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepack0101cd1f-4a95-40e9-86a8-ccde8d656e3d2025-09-23Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepack311e748a-7db4-4967-989b-5ed96871d99a2025-09-23Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepackff55a40e-4a5a-40db-87b1-7ece1d5b316f2025-09-23Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PREGABALINPREGABALINBryant Ranch Prepack72832f05-325e-4a72-8a33-da114e39c52d2025-09-23Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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