FDA.reportPublic FDA data

Omeprazole

Product NDC
71713-201
11-digit product format
717130201
Labeler code
71713
Product ID
71713-201_b3d11bd8-0ac3-363e-2e46-03fc1366a56a
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Thirty Madison Inc
Application
ANDA207740
Marketing category
ANDA
Marketing start
2019-05-31
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct71713-201DDiscontinued by firm2026-07-31
excluded packagepackage71713-20171713-201-01DDiscontinued by firm2026-07-31
excluded packagepackage71713-20171713-201-03DDiscontinued 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207740-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05

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 22:54:322026-06A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEAMERISOURCEBERGEN DRUG CORPORATION0521c51b-d113-7e35-f1a6-c4495a2bcfcc2026-04-17WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEWalmart Inc.5168ccd9-31b4-3a49-85b9-4f202cd99f6b2026-03-19WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEChain Drug Marketing Association INC77d4f6c7-87ca-78bb-3310-2304a68f9f9b2025-01-17WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Inc4b3b389d-a151-d851-cb05-64eb49979e5e2024-12-19WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEWalgreens Company5e2994fc-8f44-f6e4-71fe-44a215aa93a92024-11-10WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Incb377cb0b-14b2-04bb-f276-fd69a257f9ca2024-11-10WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740
OmeprazoleOMEPRAZOLEBluePoint Laboratoriesa86d52a5-15e2-012d-e053-2a95a90ac9122023-09-13WarningsExact identifier
application applno (ANDA): 207740
application number: ANDA207740

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71713-201-03EA - Each71713-20112b17266-8c8e-4ff4-b870-d6d65a9056fd12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71713-201OMEPRAZOLE TABLET, DELAYED RELEASE [THIRTY MADISON INC]3Legacy NDC20241030_b7289621-9dc7-fd2b-bbb1-f69dea450f7d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71713-201-01717130201011 BOTTLE in 1 CARTON (71713-201-01) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2019-05-310000-00-00NoNoCurrent
71713-201-03717130201033 BOTTLE in 1 CARTON (71713-201-03) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2019-05-310000-00-00NoNoCurrent