OMEPRAZOLE

Product NDC: 71205-960
11-digit product format: 712050960
Labeler code: 71205
Product ID: 71205-960_703a7b68-480c-4f73-9f29-ba86ce95eab3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OMEPRAZOLE
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA203481
Marketing category: ANDA
Marketing start: 2017-07-03
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 40 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71205-960		D	Discontinued by firm	2026-08-10
excluded package	package	71205-960	71205-960-00	D	Discontinued by firm	2026-08-10
excluded package	package	71205-960	71205-960-11	D	Discontinued by firm	2026-08-10
excluded package	package	71205-960	71205-960-30	D	Discontinued by firm	2026-08-10
excluded package	package	71205-960	71205-960-55	D	Discontinued by firm	2026-08-10
excluded package	package	71205-960	71205-960-60	D	Discontinued by firm	2026-08-10
excluded package	package	71205-960	71205-960-90	D	Discontinued by firm	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-960-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-960-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-960-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-960-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-960-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-960-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-960-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-960-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-960-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-960-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-960-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-960-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203481-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03
A203481-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03
A203481-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203481-001	AB
A203481-002	AB
A203481-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203481-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203481-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203481-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203481-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203481-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203481-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203481-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203481-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203481-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203481-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-960-00	EA - Each	71205-960	3b88c22c-eec6-4e0c-a3a5-473df04a44af	1	2021-06-02
71205-960-11	EA - Each	71205-960	9a75a580-f663-46e7-8079-4f24d5c5694e	1	2021-06-02
71205-960-30	EA - Each	71205-960	325b8556-618d-4430-a79e-341dfdad1818	1	2021-06-02
71205-960-55	EA - Each	71205-960	99df5955-7497-4c9c-ad29-c17b154e17f5	1	2021-06-02
71205-960-60	EA - Each	71205-960	c65194a9-82ee-4849-8dc3-6b592a2bca6b	1	2021-06-02
71205-960-90	EA - Each	71205-960	7c46dcb3-d6d8-4d9e-8ce6-cd59bf54aaa7	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-960	OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [PROFICIENT RX LP]	1	Legacy NDC	20200807_703a7b68-480c-4f73-9f29-ba86ce95eab3.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply, Inc.	f27b3518-d5c1-1229-e053-2a95a90ab56f	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203481 application number: ANDA203481
OMEPRAZOLE	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3e99b78b-7fb8-4514-a3db-58e59cd429d8	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203481 application number: ANDA203481

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-960-00	71205096000	100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-960-00)	2020-08-06	0000-00-00	No	No	Current
71205-960-11	71205096011	1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-960-11)	2020-08-06	0000-00-00	No	No	Current
71205-960-30	71205096030	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-960-30)	2020-08-06	0000-00-00	No	No	Current
71205-960-55	71205096055	500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-960-55)	2020-08-06	0000-00-00	No	No	Current
71205-960-60	71205096060	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-960-60)	2020-08-06	0000-00-00	No	No	Current
71205-960-90	71205096090	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-960-90)	2020-08-06	0000-00-00	No	No	Current