FDA.reportPublic FDA data

Omeprazole

Product NDC
69181-158
11-digit product format
691810158
Labeler code
69181
Product ID
69181-158_005dd5ee-80ee-4e89-9c63-96e8d57b503a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Midwest Drug Distribution, Inc.
Application
ANDA075576
Marketing category
ANDA
Marketing start
2015-02-04
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69181-158-142020-01-31C16284748780-19d75b9d0-2d19-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use omeprazole safely and effectively. See full prescribing information for omeprazole. OMEPRAZOLE delayed-release capsules USP, for oral use INITIAL U.S. APPROVAL: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69181-158-14Omeprazole14 in 1 PACKAGECAPSULE, DELAYED RELEASE141

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
omeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
crospovidoneINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
mannitolINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
meglumineINACTIVE INGREDIENT6HG8UB2MUYOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
methacrylic acid - ethyl acrylate copolymer (1:1) type AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
shellacINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69181-158OMEPRAZOLE CAPSULE, DELAYED RELEASE [MIDWEST DRUG DISTRIBUTION, INC.]1Legacy NDC, 1 package rows20150204_ed5e0d81-0c1a-4548-bde3-03fff123f12e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNed5e0d81-0c1a-4548-bde3-03fff123f12e1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDed5e0d81-0c1a-4548-bde3-03fff123f12e1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYed5e0d81-0c1a-4548-bde3-03fff123f12e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69181-158-146918101581414 in 1 PACKAGEHistorical