Omeprazole

Product NDC: 63868-471
11-digit product format: 638680471
Labeler code: 63868
Product ID: 63868-471_bbbf9415-a533-1629-8f52-3f286fdc2d46
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Chain Drug Marketing Association INC
Application: ANDA207740
Marketing category: ANDA
Marketing start: 2020-02-01
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63868-471		I	Inactivated by FDA	2026-08-17
excluded package	package	63868-471	63868-471-14	I	Inactivated by FDA	2026-08-17
excluded package	package	63868-471	63868-471-42	I	Inactivated by FDA	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207740-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL			2018-11-05

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-471-14	EA - Each	63868-471	91455853-0fc3-4664-a2a0-d91c70d4e8c7	1	2022-10-06
63868-471-42	EA - Each	63868-471	c15f7595-88c6-4cf1-87d0-85db17be163a	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-471	OMEPRAZOLE TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]	4	Current NDC, Legacy NDC	20241112_0057cb91-fc5e-8e9d-a926-299405c5c3a8.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	AMERISOURCEBERGEN DRUG CORPORATION	0521c51b-d113-7e35-f1a6-c4495a2bcfcc	2026-04-17	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Walmart Inc.	5168ccd9-31b4-3a49-85b9-4f202cd99f6b	2026-03-19	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Chain Drug Marketing Association INC	77d4f6c7-87ca-78bb-3310-2304a68f9f9b	2025-01-17	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Dr. Reddys Laboratories Inc	4b3b389d-a151-d851-cb05-64eb49979e5e	2024-12-19	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Walgreens Company	5e2994fc-8f44-f6e4-71fe-44a215aa93a9	2024-11-10	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Dr. Reddys Laboratories Inc	b377cb0b-14b2-04bb-f276-fd69a257f9ca	2024-11-10	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	BluePoint Laboratories	a86d52a5-15e2-012d-e053-2a95a90ac912	2023-09-13	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740

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	0057cb91-fc5e-8e9d-a926-299405c5c3a8	4
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	0057cb91-fc5e-8e9d-a926-299405c5c3a8	4
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	0057cb91-fc5e-8e9d-a926-299405c5c3a8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-471-14	63868047114	1 BOTTLE in 1 CARTON (63868-471-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2020-02-01	0000-00-00	No	No	Current
63868-471-42	63868047142	3 BOTTLE in 1 CARTON (63868-471-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	3 bottle	2020-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole Delayed Release Tablets	Chain Drug Marketing Association INC	2024-11-10	HUMAN OTC DRUG LABEL	4