FDA.reportPublic FDA data

Omeprazole Magnesium

Product NDC
63868-177
11-digit product format
638680177
Labeler code
63868
Product ID
63868-177_e72ac24f-25b4-187c-d268-fad695c76052
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
ANDA078878
Marketing category
ANDA
Marketing start
2016-01-01
Substance
OMEPRAZOLE MAGNESIUM
Active strength
20 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 Magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui198051

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-177-15EA - Each63868-177708dc9a4-4a2c-4877-a49f-01c075985ff812021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLE MAGNESIUMACTIVE INGREDIENT426QFE7XLKOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
omeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
RAW SUGARINACTIVE INGREDIENT8M707QY5GHOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-177OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]7Current NDC, Legacy NDC20240816_fdf1259b-e9d3-70a9-c209-e2eb6b152841.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNfdf1259b-e9d3-70a9-c209-e2eb6b1528418
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDfdf1259b-e9d3-70a9-c209-e2eb6b1528418
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYfdf1259b-e9d3-70a9-c209-e2eb6b1528418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-177-15638680177151 BOTTLE in 1 CARTON (63868-177-15) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2016-01-010000-00-00NoNoCurrent
63868-177-42638680177423 BOTTLE in 1 CARTON (63868-177-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2016-01-010000-00-00NoNoCurrent