FDA.reportPublic FDA data

Omeprazole

Product NDC
57896-960
Requested package NDC
57896-960-42
11-digit product format
578960960
Labeler code
57896
Product ID
57896-960_9a633bfa-188d-dd42-e053-2995a90ad3aa
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
GERICARE PHARMACEUTICALS
Application
ANDA207740
Marketing category
ANDA
Marketing start
2018-11-06
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57896-96057896-960-42DDiscontinued 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 · 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
57896-960-42EA - Each57896-960d5d3bcfc-7769-483b-b0e9-874a1255929512019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-960-42578960960423 BOTTLE in 1 CARTON (57896-960-42) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57896-960-14) 3 bottle2018-11-060000-00-00NoNoCurrent