Omeprazole

Product NDC: 69230-318
11-digit product format: 692300318
Labeler code: 69230
Product ID: 69230-318_ee873df8-2b35-9bc7-e053-2a95a90a0f83
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Camber Consumer Care Inc
Application: ANDA211732
Marketing category: ANDA
Marketing start: 2020-03-25
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211732-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2020-03-25

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9c856d3a-e38f-4006-a43a-ec1a9fa0f057	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69230-318-05	Omeprazole	500 in 1 BOTTLE	TABLET, DELAYED RELEASE	500	5
69230-318-10	Omeprazole	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	5
69230-318-32	Omeprazole	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	5
69230-318-32	Omeprazole	14 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	14	5
69230-318-33	Omeprazole	2 in 1 CARTON	TABLET, DELAYED RELEASE	2	5
69230-318-33	Omeprazole	14 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	14	5
69230-318-34	Omeprazole	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	5
69230-318-34	Omeprazole	14 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	14	5
69230-318-35	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	5
69230-318-35	Omeprazole	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	5
69230-318-36	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	5
69230-318-36	Omeprazole	2 in 1 CARTON	TABLET, DELAYED RELEASE	2	5
69230-318-37	Omeprazole	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	5
69230-318-37	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69230-318-31	EA - Each	69230-318	4a57d6cd-427e-4cad-8365-1e23dd5f380e	1	2021-04-08
69230-318-35	EA - Each	69230-318	006859ef-5ea8-45d9-8819-bf69c2544013	1	2021-04-08
69230-318-36	EA - Each	69230-318	f09f87a8-decb-4440-a2f4-1b186aa9a136	1	2021-04-08
69230-318-37	EA - Each	69230-318	7205699e-0a21-476d-af84-77ad10f875be	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69230-318	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [CAMBER CONSUMER CARE INC]	5	Current NDC, Legacy NDC, 14 package rows	20221129_9c856d3a-e38f-4006-a43a-ec1a9fa0f057.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Allegiant Health	3344c589-c4ac-4f2d-8d32-828db4e825a6	2025-03-19	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732
Omeprazole	OMEPRAZOLE	CHAIN DRUG MARKETING ASSOCIATION, INC.	da09aac6-8fce-448b-98ba-1fc9bce42075	2024-04-17	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a52842ac-ac9d-4344-9823-b8b2afb07903	2023-12-14	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732
Omeprazole	OMEPRAZOLE	Camber Consumer Care Inc	9c856d3a-e38f-4006-a43a-ec1a9fa0f057	2022-11-28	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732 ndc (product): 69230-318

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	9c856d3a-e38f-4006-a43a-ec1a9fa0f057	5
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	9c856d3a-e38f-4006-a43a-ec1a9fa0f057	5
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	9c856d3a-e38f-4006-a43a-ec1a9fa0f057	5
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	a52842ac-ac9d-4344-9823-b8b2afb07903	1
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	a52842ac-ac9d-4344-9823-b8b2afb07903	1
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	a52842ac-ac9d-4344-9823-b8b2afb07903	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69230-318-05	69230031805	500 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-05)		2020-10-29	0000-00-00	No	No	Current
69230-318-10	69230031810	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10)		2020-10-29	0000-00-00	No	No	Current
69230-318-32	69230031832	1 BLISTER PACK in 1 CARTON (69230-318-32) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK	1 blister pack	2020-03-25	0000-00-00	No	No	Current
69230-318-33	69230031833	2 BLISTER PACK in 1 CARTON (69230-318-33) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK	2 blister pack	2020-03-25	0000-00-00	No	No	Current
69230-318-34	69230031834	3 BLISTER PACK in 1 CARTON (69230-318-34) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK	3 blister pack	2020-03-25	0000-00-00	No	No	Current
69230-318-35	69230031835	1 BOTTLE in 1 CARTON (69230-318-35) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2020-03-25	0000-00-00	No	No	Current
69230-318-36	69230031836	2 BOTTLE in 1 CARTON (69230-318-36) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	2 bottle	2020-03-25	0000-00-00	No	No	Current
69230-318-37	69230031837	3 BOTTLE in 1 CARTON (69230-318-37) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	3 bottle	2020-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole Delayed-Release Tablets, 20 mg/acid reducer	A-S Medication Solutions	2023-12-14	HUMAN OTC DRUG LABEL	1
Omeprazole Delayed-Release Tablets, 20 mg/acid reducer	Camber Consumer Care Inc \| Hetero Labs Limited Unit III	2022-11-28	HUMAN OTC DRUG LABEL	5