FDA.reportPublic FDA data

NDC 69097-679-19 - PREGABALIN capsules, CV

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
69097-679
Requested NDC
69097-679-19
Package NDCs from labels
69097-679-02, 69097-679-05, 69097-679-12, 69097-679-19, 69097-679-21
Manufacturer
Cipla USA Inc. | CIPLA LIMITED KURKUMBH
Effective date
2025-12-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PREGABALIN capsules, CV - Cipla USA Inc. | CIPLA LIMITED KURKUMBHCipla USA Inc. | CIPLA LIMITED KURKUMBH2025-12-22HUMAN PRESCRIPTION DRUG LABEL
PREGABALIN capsules, CV - A-S Medication SolutionsA-S Medication Solutions2022-03-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-679-02PREGABALIN capsules, CV30 in 1 BOTTLECAPSULE309
69097-679-05PREGABALIN capsules, CV90 in 1 BOTTLECAPSULE909
69097-679-12PREGABALIN capsules, CV500 in 1 BOTTLECAPSULE5009
69097-679-19PREGABALIN capsules, CV10 in 1 BLISTER PACKCAPSULE109
69097-679-21PREGABALIN capsules, CV100 in 1 CARTONCAPSULE1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-679PREGABALIN CAPSULES, CV CAPSULE [CIPLA USA INC.]7Current NDC, Legacy NDC, 5 package rows20211123_7d93359c-1849-430d-a922-21d42932d0f3.zip

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 3 of 125 · 2,487 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.5d738807-7f88-4943-9c3b-01f1e52ea72d2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
PregabalinPREGABALINAscend Laboratories, LLCe48db3c2-7351-41f2-a451-5a8341c4125c2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINREMEDYREPACK INC.9685792b-911d-4cf9-9881-d21abca48c662026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.c60752f8-20d5-4333-bf33-a656eab01d6b2026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINREMEDYREPACK INC.0f72ec70-314c-4c9f-86be-54f3e010356d2026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 483444
unii: 55JG375S6M
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINREMEDYREPACK INC.91edbe87-cd22-43a5-9952-1cd523b138202026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 483446
unii: 55JG375S6M
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
PregabalinPREGABALINREMEDYREPACK INC.14f3f9ba-7a4a-45d5-a25e-efe5cdff117d2026-07-28Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PregabalinPREGABALINBryant Ranch Prepack1e6fa742-f658-495f-88bb-8eddf9a45ffe2026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 483444
unii: 55JG375S6M
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
PregabalinPREGABALINBryant Ranch Prepack48798c13-3ef4-4e7f-9f73-92dccac0af142026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
PREGABALINPREGABALINCardinal Health 107, LLC124176c7-d8ab-4bbe-b468-3e5d12f03e442026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 483448
rxcui: 483438
rxcui: 483450
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

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