FDA.reportPublic FDA data

NDC 68788-7523-01 - 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
68788-7523
Requested NDC
68788-7523-01
Package NDCs from labels
68788-7523-3, 68788-7523-6, 68788-7523-9, 68788-7523-1, 68788-7523-01
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2025-09-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pregabalin - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2025-09-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7523-1Pregabalin100 in 1 BOTTLECAPSULE1007
68788-7523-3Pregabalin30 in 1 BOTTLECAPSULE307
68788-7523-6Pregabalin60 in 1 BOTTLECAPSULE607
68788-7523-9Pregabalin90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7523PREGABALIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20240805_ceedde96-fdaf-4708-9ca1-e48e052cde75.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7523-1EA - Each68788-752361eae38c-8931-44be-83ec-a644ce3bfbc412019-11-12
68788-7523-3EA - Each68788-75237e6928bb-db3b-4d06-9762-69ea0f8655d712019-11-12
68788-7523-6EA - Each68788-75233e3774cd-406b-48e7-b32f-52bbc17d94b412019-11-12
68788-7523-9EA - Each68788-75238cc89d7e-1722-48db-bfab-64048114b48f12019-11-12

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 118 · 2,354 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.ab06a36d-9a2d-4eae-8991-4eab5bc8311c2026-09-11Warnings, Adverse reactionsExact identifier
rxcui: 483442
unii: 55JG375S6M
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINClinical Solutions Wholesale, LLC93c2fe8b-67d7-4a15-8790-5595e158b3ab2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.e897d7e8-2743-4512-8417-375cb11ceec62026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 483442
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.84bf3abb-559d-4140-a689-f3e26b1c4ff22026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA208677
rxcui: 483440
unii: 55JG375S6M
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINPreferred Pharmaceuticals Inc.7f29991e-3bf5-4e48-8fa3-6d4e932ed6de2026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ce1419bc-c348-4407-b320-e0598d5a7b192026-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA208677
rxcui: 483442
unii: 55JG375S6M
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 483442
unii: 55JG375S6M
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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