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 5 of 21 · 415 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINBryant Ranch Prepack247aedca-ae27-44c6-b32c-c95d264545662026-04-07Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepacke1ed81bc-1597-4bc5-80cd-09977a154e4b2026-04-07Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 22ADO53M6F
PregabalinPREGABALINBryant Ranch Prepackfd568ede-dac7-4910-bb18-65fb00f2636e2026-04-07Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINProficient Rx LP32789571-a566-46fa-ba41-bd3c86276ecf2026-04-01Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY3dd7930b-f544-f18b-e063-6294a90a05412026-03-31Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepackc60f6b1e-7a24-41b2-8435-e20583a732c62026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack52e36f66-4c4a-4fc5-968b-46879b7bf1db2026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepackdf382975-73f1-4957-8959-177848f796f72026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack90b65884-4222-4011-b042-88b83e51c57a2026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepackdbf3647a-5ab1-450e-be5f-69b8441855722026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepackbe8d51d7-ae26-4fc7-9457-a4ad84523fd72026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack9053ff4e-cc47-4fa8-990a-4b0d539a480a2026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack36085f4e-91ae-458c-b0a0-81363112df012026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack47cc53e6-e679-4a01-babc-af301dd756f72026-03-30Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4db38263-899a-8405-e063-6294a90a44082026-03-25Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf514f-3922-624b-e063-6394a90a8f6b2026-03-25Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf7b9b-7b72-913c-e063-6394a90af3a42026-03-25Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 22ADO53M6F

Reported adverse events (FAERS/openFDA)#

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