NDC 55111-643-79 - Omeprazole

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
55111-643
Requested NDC
55111-643-79
Package NDCs from labels
55111-643-30, 55111-643-01, 55111-643-05, 55111-643-79, 55111-643-78
Manufacturer
Proficient Rx LP
Effective date
2026-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Omeprazole - Proficient Rx LPProficient Rx LP2026-08-01HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO IIIDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO III2026-03-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-643-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10034
55111-643-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50034
55111-643-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3034
55111-643-78Omeprazole10 in 1 CARTONCAPSULE, DELAYED RELEASE1034
55111-643-79Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1034

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-643OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]30Current NDC, Legacy NDC, 5 package rows20240616_603d2d06-c5e8-4378-a422-8dca1a410af7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-643-01EA - Each55111-643494e577b-97a6-4012-afd1-f4208307ef8812026-03-17
55111-643-30EA - Each55111-643144bd8d5-7399-43a1-bdf3-74516a41819c12026-03-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
gelatinINACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
meglumineINACTIVE INGREDIENT6HG8UB2MUYOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
propylene glycolINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
RAW SUGARINACTIVE INGREDIENT8M707QY5GHOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
talcINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15

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 29 of 121 · 2,404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Fresh and Soothe Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKC Pharmaceuticals, Inc.1f65b91a-4eac-65c2-e063-6394a90a02952025-12-30WarningsExact identifier
unii: 6DC9Q167V3
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: 3NXW29V3WO
DG Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLDolgencorp LLC9cb27899-6c36-3c37-e053-2995a90a1d432025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Publix High Performance Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLPublix Super Markets, Inc.9b402aa8-87cb-3928-e053-2995a90afa3c2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: 3NXW29V3WO
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
unii: 15FIX9V2JP
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLENorthwind Health Company, LLC4720cc17-013e-074e-e063-6294a90ac1f42025-12-29Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 200329
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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