FDA.reportPublic FDA data

Omeprazole

Product NDC
0093-5294
11-digit product format
000935294
Labeler code
0093
Product ID
0093-5294_74764042-44bb-4b8b-b062-16675650a6aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA204661
Marketing category
ANDA
Marketing start
2017-08-08
Marketing end
2020-05-31
Substance
OMEPRAZOLE
Active strength
40 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-5294DDiscontinued by firm2026-07-31
excluded packagepackage0093-52940093-5294-10DDiscontinued by firm2026-07-31
excluded packagepackage0093-52940093-5294-56DDiscontinued by firm2026-07-31
excluded packagepackage0093-52940093-5294-98DDiscontinued by firm2026-07-31

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204661-001OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-06-13
A204661-002OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2017-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204661-001AB

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 22:54:322026-06A204661-001OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-06-13a50c72e98297…
2026-08-01 22:54:322026-06A204661-002OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2017-06-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204661-001AB1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5294-10EA - Each0093-5294c5205303-591d-4e68-a722-109dd81a8ccb12017-09-11
0093-5294-56EA - Each0093-5294aa544b57-5074-4585-a295-cfec1992624912017-09-11
0093-5294-98EA - Each0093-52948bd522aa-82df-45ab-bf71-f57cd436784712017-09-11