FDA.reportPublic FDA data

Omeprazole

Product NDC
0378-5211
11-digit product format
003785211
Labeler code
0378
Product ID
0378-5211_54a04f22-d835-47c6-b249-252b68f9074a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075876
Marketing category
ANDA
Marketing start
2003-08-04
Marketing end
2019-05-31
Substance
OMEPRAZOLE
Active strength
10 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-5211DDiscontinued by firm2026-08-03
excluded packagepackage0378-52110378-5211-93DDiscontinued by firm2026-08-03
excluded packagepackage0378-52110378-5211-95DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075876-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29
A075876-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29
A075876-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29a50c72e98297…
2026-08-01 22:54:322026-06A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29a50c72e98297…
2026-08-01 22:54:322026-06A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5211-93EA - Each0378-5211850df012-3f19-4de5-85a1-55c3cfe9e02912012-07-24
0378-5211-95EA - Each0378-5211721a010a-87fd-4e3f-9160-9aa1380783c512017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
SUCROSEINACTIVE INGREDIENTC151H8M554OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12