FDA.reportPublic FDA data

omeprazole

Product NDC
31722-527
11-digit product format
317220527
Labeler code
31722
Product ID
31722-527_2b439e93-9a24-e64a-e063-6394a90a634f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204012
Marketing category
ANDA
Marketing start
2019-09-26
Substance
OMEPRAZOLE
Active strength
10 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204012-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2019-09-26
A204012-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2019-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204012-001AB
A204012-002AB

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 22:54:322026-06A204012-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2019-09-26a50c72e98297…
2026-08-01 22:54:322026-06A204012-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2019-09-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204012-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204012-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLECamber Pharmaceuticals, Inc.0c6e00a2-31e8-4e84-928d-80e69a5fc6342025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204012
application number: ANDA204012
ndc (product): 31722-527

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE10 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198051Internal RxNorm lookup
199119Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c6e00a2-31e8-4e84-928d-80e69a5fc634Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-527-01omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1002
31722-527-30omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-527OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20250110_0c6e00a2-31e8-4e84-928d-80e69a5fc634.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN0c6e00a2-31e8-4e84-928d-80e69a5fc6342
198051omeprazole 20 MG Delayed Release Oral CapsulePSN0c6e00a2-31e8-4e84-928d-80e69a5fc6342
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD0c6e00a2-31e8-4e84-928d-80e69a5fc6342
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD0c6e00a2-31e8-4e84-928d-80e69a5fc6342
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY0c6e00a2-31e8-4e84-928d-80e69a5fc6342
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY0c6e00a2-31e8-4e84-928d-80e69a5fc6342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-527-0131722052701100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-527-01) 2019-09-260000-00-00NoNoCurrent
31722-527-303172205273030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-527-30) 2019-09-260000-00-00NoNoCurrent