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 18 of 122 · 2,433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.fa5046f2-a6db-4ac3-a78f-1b5df075d7e82026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.0c5fc63f-1899-4406-944a-1cdcdf8b42772026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.58a84ecd-3f27-40fc-8e0b-e29192679e6b2026-01-21WarningsExact identifier
unii: 15FIX9V2JP
sunscreenTITANIUM DIOXIDEGuangdong Zhoubang Biotechnology Co., Ltd48f13b1c-8104-881b-e063-6394a90a816d2026-01-21WarningsExact identifier
unii: 15FIX9V2JP
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
unii: 15FIX9V2JP
KONEUK SUNSCREEN SPF50KONEUK SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.48dd7f6e-2a4d-2c92-e063-6294a90a42552026-01-20WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2026-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 200329
unii: KG60484QX9
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEGlenmark Pharmaceuticals Inc., USAc6c22be1-659d-4e71-b292-701e27da201b2026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior25abef37-1726-491f-8a11-ac1a96378ed12026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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