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 1 of 21 · 415 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.ab06a36d-9a2d-4eae-8991-4eab5bc8311c2026-09-11Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINClinical Solutions Wholesale, LLC93c2fe8b-67d7-4a15-8790-5595e158b3ab2026-09-09Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.e897d7e8-2743-4512-8417-375cb11ceec62026-09-03Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.84bf3abb-559d-4140-a689-f3e26b1c4ff22026-09-02Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-09-01Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINPreferred Pharmaceuticals Inc.7f29991e-3bf5-4e48-8fa3-6d4e932ed6de2026-08-21Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ce1419bc-c348-4407-b320-e0598d5a7b192026-08-21Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-08-20Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINREMEDYREPACK INC.12309847-0857-4ff7-a7e7-edeadc3dfb612026-08-14Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.47d08b8f-a24d-4159-ab43-2eb67a93559b2026-08-14Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.3c8ea6da-5771-4096-a915-700e51ced05c2026-08-14Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.9c38abbc-2b3d-48d6-b629-4a163c803db52026-08-14Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.efe06a26-30c5-437d-9fd1-4bd0062f12002026-08-14Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINREMEDYREPACK INC.f30a7a3b-d45e-4e0b-ab1b-1369b2f023202026-08-06Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.326c643a-23c5-4dab-9266-abc22ca1f8742026-08-06Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.5d738807-7f88-4943-9c3b-01f1e52ea72d2026-08-05Warnings, Adverse reactionsExact identifier
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

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