FDA.reportPublic FDA data

Omeprazole

Product NDC
68001-441
11-digit product format
680010441
Labeler code
68001
Product ID
68001-441_0486dc89-1bf1-8e37-e063-6394a90a9aa7
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA207740
Marketing category
ANDA
Marketing start
2020-06-19
Substance
OMEPRAZOLE
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

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 packagepackage68001-44168001-441-55DDiscontinued 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
ndc (product): 68001-441

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KG60484QX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402014Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a86d52a5-15e2-012d-e053-2a95a90ac912Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-441-39Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
68001-441-40Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
68001-441-55Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
68001-441-98Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-441-39EA - Each68001-441b9f2615f-136c-48a3-8d62-89c8aec834d812020-09-14
68001-441-40EA - Each68001-441bddc9777-1448-465c-9d50-440abcb9523112020-09-14
68001-441-55EA - Each68001-4410720290b-f2aa-41e2-9b89-667f6bda486112022-06-06
68001-441-98EA - Each68001-441ea82b9cb-7b5a-43b5-a198-60bcb9e85c0212020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-441OMEPRAZOLE TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]5Current NDC, Legacy NDC, 4 package rows20230914_a86d52a5-15e2-012d-e053-2a95a90ac912.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNa86d52a5-15e2-012d-e053-2a95a90ac9125
402014omeprazole 20 MG Delayed Release Oral TabletSCDa86d52a5-15e2-012d-e053-2a95a90ac9125
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYa86d52a5-15e2-012d-e053-2a95a90ac9125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-441-39680010441392 BOTTLE in 1 CARTON (68001-441-39) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) 2 bottle2020-06-190000-00-00NoNoCurrent
68001-441-40680010441403 BOTTLE in 1 CARTON (68001-441-40) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) 3 bottle2020-06-190000-00-00NoNoCurrent
68001-441-556800104415514 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) 2020-06-190000-00-00NoNoCurrent
68001-441-98680010441981 BOTTLE in 1 CARTON (68001-441-98) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) 1 bottle2020-06-190000-00-00NoNoCurrent