FDA.reportPublic FDA data

Omeprazole

Product NDC
55111-645
11-digit product format
551110645
Labeler code
55111
Product ID
55111-645_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078490
Marketing category
ANDA
Marketing start
2014-03-01
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 199119, 200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-645-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10034
55111-645-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50034
55111-645-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100034
55111-645-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3034
55111-645-34Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3034
55111-645-34Omeprazole12 in 1 CARTONCAPSULE, DELAYED RELEASE1234
55111-645-78Omeprazole10 in 1 CARTONCAPSULE, DELAYED RELEASE1034
55111-645-79Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-645-01EA - Each55111-64509e3b832-5a8a-4207-948d-31ede49cd65112014-04-03
55111-645-05EA - Each55111-64515aede77-bf15-4e6a-8eff-77b81b3562aa12014-04-03
55111-645-10EA - Each55111-6453a6ce06c-1b6d-4a33-92ab-d6f2e3982a8712025-11-13
55111-645-30EA - Each55111-64578d5bd3e-1bc4-4f75-b7c1-10707767ae9512014-04-03
55111-645-34EA - Each55111-645982fb8ee-42e8-4128-9902-628841bd5c0612015-06-09

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-645OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]30Current NDC, Legacy NDC, 8 package rows20240616_603d2d06-c5e8-4378-a422-8dca1a410af7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
200329omeprazole 40 MG Delayed Release Oral CapsulePSN0344268f-d8e6-48d5-b1e1-f750ed1d8a5234
200329omeprazole 40 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD0344268f-d8e6-48d5-b1e1-f750ed1d8a5234
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG Delayed Release Oral CapsulePSN205652e1-7fbc-4b6a-bbd6-2fd346d812df5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN205652e1-7fbc-4b6a-bbd6-2fd346d812df5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD205652e1-7fbc-4b6a-bbd6-2fd346d812df5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD205652e1-7fbc-4b6a-bbd6-2fd346d812df5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY205652e1-7fbc-4b6a-bbd6-2fd346d812df5
200329omeprazole 40 MG Delayed Release Oral CapsulePSNf77efc97-2565-38ab-e053-6394a90aebda2
200329omeprazole 40 MG Delayed Release Oral CapsulePSN288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2
200329omeprazole 40 MG Delayed Release Oral CapsulePSNf550f664-b74f-47f4-9063-0e4aff98b2392
200329omeprazole 40 MG Delayed Release Oral CapsulePSN4720cc17-013e-074e-e063-6294a90ac1f42
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD4720cc17-013e-074e-e063-6294a90ac1f42
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDf550f664-b74f-47f4-9063-0e4aff98b2392
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDf77efc97-2565-38ab-e053-6394a90aebda2
200329omeprazole 40 MG Delayed Release Oral CapsulePSNdec2cba8-3a85-6c79-e053-2a95a90aa0881
200329omeprazole 40 MG Delayed Release Oral CapsulePSN2dcd48e4-9ffc-9cc2-e063-6294a90ae17e1
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDdec2cba8-3a85-6c79-e053-2a95a90aa0881
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD2dcd48e4-9ffc-9cc2-e063-6294a90ae17e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-645-0155111064501100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-01) 2014-03-010000-00-00NoNoCurrent
55111-645-0555111064505500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-05) 2014-03-010000-00-00NoNoCurrent
55111-645-10551110645101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-10) 2025-10-01NoNoCurrent
55111-645-305511106453030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-30) 2014-03-010000-00-00NoNoCurrent
55111-645-345511106453412 BOTTLE in 1 CARTON (55111-645-34) / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE12 bottle2015-05-140000-00-00NoNoCurrent
55111-645-785511106457810 BLISTER PACK in 1 CARTON (55111-645-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-645-79) 10 blister pack2014-03-010000-00-00NoNoCurrent
55111-645-795511106457910 in 1 BLISTER PACKHistorical