FDA.reportPublic FDA data

X

Manufacturer
AX Pharmaceutical Corp
Effective date
2016-05-22
Label type
BULK INGREDIENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:48:15

Label at a glance#

ProductX
Active ingredientPREGABALIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62157-101-01X500 g in 1 BOTTLEPOWDER5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62157-101X (PREGABALIN) POWDER [AX PHARMACEUTICAL CORP]21 package rows20160523_cd8eee65-4d3d-49e5-810b-c8938a65d793.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6M1
PREGABALINACTIVE MOIETY55JG375S6M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62157-10162157-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PREGABALIN55JG375S6MACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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 12 · 225 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.ab06a36d-9a2d-4eae-8991-4eab5bc8311c2026-09-11Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINClinical Solutions Wholesale, LLC93c2fe8b-67d7-4a15-8790-5595e158b3ab2026-09-09Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.e897d7e8-2743-4512-8417-375cb11ceec62026-09-03Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.84bf3abb-559d-4140-a689-f3e26b1c4ff22026-09-02Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-09-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals Inc.7f29991e-3bf5-4e48-8fa3-6d4e932ed6de2026-08-21Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ce1419bc-c348-4407-b320-e0598d5a7b192026-08-21Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-08-20Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.12309847-0857-4ff7-a7e7-edeadc3dfb612026-08-14Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.47d08b8f-a24d-4159-ab43-2eb67a93559b2026-08-14Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.3c8ea6da-5771-4096-a915-700e51ced05c2026-08-14Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.9c38abbc-2b3d-48d6-b629-4a163c803db52026-08-14Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.efe06a26-30c5-437d-9fd1-4bd0062f12002026-08-14Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.f30a7a3b-d45e-4e0b-ab1b-1369b2f023202026-08-06Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.326c643a-23c5-4dab-9266-abc22ca1f8742026-08-06Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.5d738807-7f88-4943-9c3b-01f1e52ea72d2026-08-05Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAscend Laboratories, LLCe48db3c2-7351-41f2-a451-5a8341c4125c2026-08-04Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.9685792b-911d-4cf9-9881-d21abca48c662026-08-03Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.c60752f8-20d5-4333-bf33-a656eab01d6b2026-08-03Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.0f72ec70-314c-4c9f-86be-54f3e010356d2026-08-03Warnings, Adverse reactionsName fallback
generic name: PREGABALIN

Reported adverse events (FAERS/openFDA)#

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