FDA.reportPublic FDA data

Omeprazole

Product NDC
0363-1607
11-digit product format
003631607
Labeler code
0363
Product ID
0363-1607_663561b1-18c8-7edf-9559-d226dc32a683
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreens Company
Application
ANDA207740
Marketing category
ANDA
Marketing start
2020-01-15
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

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
ndc (product): 0363-1607
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

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
5e2994fc-8f44-f6e4-71fe-44a215aa93a9Available 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
0363-1607-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
0363-1607-28Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE23
0363-1607-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1607OMEPRAZOLE TABLET, DELAYED RELEASE [WALGREENS COMPANY]3Current NDC, Legacy NDC, 3 package rows20241112_5e2994fc-8f44-f6e4-71fe-44a215aa93a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN5e2994fc-8f44-f6e4-71fe-44a215aa93a93
402014omeprazole 20 MG Delayed Release Oral TabletSCD5e2994fc-8f44-f6e4-71fe-44a215aa93a93
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY5e2994fc-8f44-f6e4-71fe-44a215aa93a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1607-140036316071414 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) 2020-01-150000-00-00NoNoCurrent
0363-1607-28003631607282 BOTTLE in 1 CARTON (0363-1607-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) 2 bottle2020-01-150000-00-00NoNoCurrent
0363-1607-42003631607423 BOTTLE in 1 CARTON (0363-1607-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) 3 bottle2020-01-150000-00-00NoNoCurrent