Omeprazole

Product NDC
66336-706
11-digit product format
663360706
Labeler code
66336
Product ID
66336-706_64218455-e1e2-4e40-bd32-5002d2d1555d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA075876
Marketing category
ANDA
Marketing start
2012-12-12
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
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-706-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-706-30EA - Each66336-7066ab00a2c-34e3-4781-8e1b-d69099bfdc6112013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-706OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20130704_8e3b29b0-d3a8-409a-b397-53dbbbcda094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN8e3b29b0-d3a8-409a-b397-53dbbbcda0941
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD8e3b29b0-d3a8-409a-b397-53dbbbcda0941
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY8e3b29b0-d3a8-409a-b397-53dbbbcda0941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-706-306633607063030 in 1 BOTTLE, PLASTICHistorical