Omeprazole

Product NDC: 55111-643
11-digit product format: 551110643
Labeler code: 55111
Product ID: 55111-643_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA078490
Marketing category: ANDA
Marketing start: 2014-03-01
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078490-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17
A078490-002	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16
A078490-003	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078490-001	AB
A078490-002	AB
A078490-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078490-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078490-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	10 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
199119	Internal RxNorm lookup
200329	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
603d2d06-c5e8-4378-a422-8dca1a410af7	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
55111-643-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	34
55111-643-05	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	34
55111-643-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	34
55111-643-78	Omeprazole	10 in 1 CARTON	CAPSULE, DELAYED RELEASE	10	34
55111-643-79	Omeprazole	10 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	10	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-643-01	EA - Each	55111-643	494e577b-97a6-4012-afd1-f4208307ef88	1	2026-03-17
55111-643-30	EA - Each	55111-643	144bd8d5-7399-43a1-bdf3-74516a41819c	1	2026-03-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
gelatin	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
meglumine	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
RAW SUGAR	INACTIVE INGREDIENT	8M707QY5GH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
talc	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-643	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	30	Current NDC, Legacy NDC, 5 package rows	20240616_603d2d06-c5e8-4378-a422-8dca1a410af7.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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	a806da8c-5f84-454d-966c-da1c48710f80	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	AvPAK	f77efc97-2565-38ab-e053-6394a90aebda	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole DR	OMEPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	b4cd8ed1-d9d3-5b57-e053-2995a90a9f3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	59d8be3f-ba13-4897-9ceb-f8ac6ccc1624	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	487ff32f-943e-458b-b898-bd7b0290cc49	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	c8f2e604-74fa-4205-b41f-32401e2dc59e	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a656a059-2b1a-44b3-85f8-af278032b54c	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8f13fd38-dc73-4072-bdc9-9474704a4121	2023-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490

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
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	603d2d06-c5e8-4378-a422-8dca1a410af7	34
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	603d2d06-c5e8-4378-a422-8dca1a410af7	34
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	603d2d06-c5e8-4378-a422-8dca1a410af7	34
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	603d2d06-c5e8-4378-a422-8dca1a410af7	34
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	603d2d06-c5e8-4378-a422-8dca1a410af7	34
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	603d2d06-c5e8-4378-a422-8dca1a410af7	34
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	603d2d06-c5e8-4378-a422-8dca1a410af7	34
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	603d2d06-c5e8-4378-a422-8dca1a410af7	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-643-01	55111064301	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-01)		2026-03-09	0000-00-00	No	No	Current
55111-643-05	55111064305	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-05)		2014-03-01	0000-00-00	No	No	Current
55111-643-30	55111064330	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-30)		2026-03-09	0000-00-00	No	No	Current
55111-643-78	55111064378	10 BLISTER PACK in 1 CARTON (55111-643-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-643-79)	10 blister pack	2014-03-01	0000-00-00	No	No	Current
55111-643-79	55111064379	10 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Proficient Rx LP	2026-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited - FTO III	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	34