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 4 of 21 · 415 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINBryant Ranch Prepack45abbcb4-6a38-469d-9671-24b2c25e5b182026-05-15Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINUnichem Pharmaceuticals (USA), Inc.284f2c15-24ef-466b-8110-3c2e874835092026-05-11Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf9ede-5e8b-b5e1-e063-6394a90ac7f32026-05-05Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP34846423-e747-42c5-9bcd-f99c557c4f672026-05-01Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d53c8e2-f03f-0f5b-e063-6294a90a23c62026-04-27Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ef59b1c-1273-5e54-e063-6294a90a0ec92026-04-21Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAurobindo Pharma Limited11034861-eef2-4996-8082-afc3c17691712026-04-15Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3d9d7123-5886-4b61-a7ea-471b213e77d92026-04-14Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack1a8d8292-1f94-46da-bade-8c40542013432026-04-13Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepackb977269a-7d62-44a2-bd0d-11c54b8728362026-04-10Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepackfd01590e-5b90-4a77-ad5f-76adabf3c32e2026-04-09Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4d63908b-96be-554c-e063-6394a90af5102026-04-08Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack8a7acea4-108d-40d2-a2a7-36088be972482026-04-07Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack025c3adb-5f6b-45f5-a4c6-cea8e57102e32026-04-07Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack2ceccc4d-97e2-4eb0-841f-23609187710c2026-04-07Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

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