FDA.reportPublic FDA data

Omeprazole

Product NDC
68382-500
11-digit product format
683820500
Labeler code
68382
Product ID
68382-500_d0074baa-52cb-4039-9bd8-966a36ff70da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA091352
Marketing category
ANDA
Marketing start
2012-11-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2026-12-31

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
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
68382-500-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10018
68382-500-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50018
68382-500-06Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3018
68382-500-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100018
68382-500-16Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-500-01EA - Each68382-5009f38270b-798d-4d74-b70c-a6dd5d430e3312013-02-13
68382-500-05EA - Each68382-500a8732bfb-f59e-4530-b0e7-8f6763bab1cc12025-11-13
68382-500-06EA - Each68382-5001ecab414-0d08-44e2-964a-7893feadea7d12013-02-13
68382-500-10EA - Each68382-500d342fd33-7a98-40ac-896b-90a2ac8215c512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
ACETONEINACTIVE INGREDIENT1364PS73AFOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671POMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)INACTIVE INGREDIENT8LDD2V82F5OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-500OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]18Current NDC, Legacy NDC, 5 package rows20230513_9c22ceb2-2c34-43c3-9a35-2589c9078741.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN39e3b45a-8e9b-49d6-976a-6668f4e27649100
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD39e3b45a-8e9b-49d6-976a-6668f4e27649100
199119omeprazole 10 MG Delayed Release Oral CapsulePSN9c22ceb2-2c34-43c3-9a35-2589c907874118
198051omeprazole 20 MG Delayed Release Oral CapsulePSN9c22ceb2-2c34-43c3-9a35-2589c907874118
200329omeprazole 40 MG Delayed Release Oral CapsulePSN9c22ceb2-2c34-43c3-9a35-2589c907874118
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD9c22ceb2-2c34-43c3-9a35-2589c907874118
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD9c22ceb2-2c34-43c3-9a35-2589c907874118
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD9c22ceb2-2c34-43c3-9a35-2589c907874118
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY9c22ceb2-2c34-43c3-9a35-2589c907874118
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY9c22ceb2-2c34-43c3-9a35-2589c907874118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-500-0168382050001100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-500-01) 2012-11-230000-00-00NoNoCurrent
68382-500-0568382050005500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-500-05) 2012-11-230000-00-00NoNoCurrent
68382-500-066838205000630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-500-06) 2012-11-230000-00-00NoNoCurrent
68382-500-10683820500101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-500-10) 2012-11-230000-00-00NoNoCurrent
68382-500-166838205001690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-500-16) 2012-11-230000-00-00NoNoCurrent