ZEGERID

Product NDC: 68012-104
11-digit product format: 680120104
Labeler code: 68012
Product ID: 68012-104_1d076bd0-8cc0-4327-8032-9a307fc89e71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole and sodium bicarbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: Santarus, Inc..
Application: NDA021849
Marketing category: NDA
Marketing start: 2006-02-27
Substance: OMEPRAZOLE; SODIUM BICARBONATE
Active strength: 40; 1100 mg/1; mg/1
Pharmacologic classes: Alkalinizing Activity [MoA], 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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021849-001	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27
N021849-002	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021849-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021849-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021849-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021849-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021849-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021849-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021849-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021849-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021849-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021849-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021849-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021849-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021849-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021849-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021849-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021849-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021849-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021849-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021849-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021849-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021849-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021849-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021849-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021849-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021849-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021849-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021849-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021849-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021849-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021849-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021849-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021849-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021849-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021849-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021849-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021849-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021849-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021849-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021849-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021849-002	AB	1	`3f0d92c62455…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	40 mg/1
SODIUM BICARBONATE	1100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup
8MDF5V39QO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616539	Internal RxNorm lookup
616541	Internal RxNorm lookup
646344	Internal RxNorm lookup
646352	Internal RxNorm lookup
753557	Internal RxNorm lookup
753562	Internal RxNorm lookup
753601	Internal RxNorm lookup
753603	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
cd6868b9-5824-442b-8d65-4db29ecb70a4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68012-104-05	ZEGERID	5 in 1 BOTTLE	CAPSULE	5		53
68012-104-30	ZEGERID	30 in 1 BOTTLE	CAPSULE	30		53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68012-104-30	EA - Each	68012-104	e3d0c117-1de4-4096-9fce-7d115c1e91ef	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
SODIUM BICARBONATE	ACTIVE INGREDIENT	8MDF5V39QO	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
BICARBONATE ION	ACTIVE MOIETY	HN1ZRA3Q20	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]	32
omeprazole	ACTIVE INGREDIENT	KG60484QX9	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
sodium bicarbonate	ACTIVE INGREDIENT	8MDF5V39QO	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
bicarbonate ion	ACTIVE MOIETY	HN1ZRA3Q20	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
omeprazole	ACTIVE MOIETY	KG60484QX9	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
sodium stearyl fumarate	INACTIVE INGREDIENT	7CV7WJK4UI	ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68012-104	ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [SANTARUS, INC..]	52	Current NDC, Legacy NDC, 2 package rows	20230729_cd6868b9-5824-442b-8d65-4db29ecb70a4.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 and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Oceanside Pharmaceuticals	c26b6893-8264-4d4a-ac7e-1ddda933451e	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021849 application number: NDA021849
ZEGERID	OMEPRAZOLE AND SODIUM BICARBONATE	Santarus, Inc..	cd6868b9-5824-442b-8d65-4db29ecb70a4	2023-07-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021849 application number: NDA021849 ndc (product): 68012-104

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
616539	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule	PSN	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753562	omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	PSN	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
616541	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule	PSN	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753557	omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	PSN	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646344	Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006	PSN	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753603	Zegerid 20 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006	PSN	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646352	Zegerid 40 MG / 1100 MG Oral Capsule, Reformulated Aug 2006	PSN	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753601	Zegerid 40 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006	PSN	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646344	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]	SBD	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753603	omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006]	SBD	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646352	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]	SBD	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753601	omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006]	SBD	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
616539	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule	SCD	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753562	omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	SCD	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
616541	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule	SCD	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753557	omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	SCD	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
616539	Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646344	Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753562	Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753603	Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006]	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
616541	Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646352	Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753557	Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral Suspension	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753601	Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006]	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646344	Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753603	Zegerid (omeprazole 20 MG / sodium bicarbonate 1680 MG) Powder for Oral Suspension, Reformulated Aug 2006	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753601	Zegerid (omeprazole 40 MG / sodium bicarbonate 1680 MG) Powder for Oral Suspension, Reformulated Aug 2006	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753603	Zegerid 20 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
753601	Zegerid 40 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646344	Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
646352	Zegerid Reformulated Aug 2006 (omeprazole 40 MG / sodium bicarbonate 1100 MG) Oral Capsule	SY	cd6868b9-5824-442b-8d65-4db29ecb70a4	53
616541	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule	PSN	b92afca2-4526-474d-a023-858f1d1f166f	1
646352	Zegerid 40 MG / 1100 MG Oral Capsule, Reformulated Aug 2006	PSN	b92afca2-4526-474d-a023-858f1d1f166f	1
646352	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]	SBD	b92afca2-4526-474d-a023-858f1d1f166f	1
616541	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule	SCD	b92afca2-4526-474d-a023-858f1d1f166f	1
616541	Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule	SY	b92afca2-4526-474d-a023-858f1d1f166f	1
646352	Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]	SY	b92afca2-4526-474d-a023-858f1d1f166f	1
646352	Zegerid Reformulated Aug 2006 (omeprazole 40 MG / sodium bicarbonate 1100 MG) Oral Capsule	SY	b92afca2-4526-474d-a023-858f1d1f166f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68012-104-05	68012010405	5 CAPSULE in 1 BOTTLE (68012-104-05)	5 capsule	2006-02-27	0000-00-00	No	No	Current
68012-104-30	68012010430	30 CAPSULE in 1 BOTTLE (68012-104-30)	30 capsule	2006-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZEGERID	Santarus, Inc.. \| Salix Pharmaceuticals, Inc. \| Norwich Pharmaceuticals, Inc. \| Patheon Inc. \| Pharma Packaging Solutions, LLC dba Tjoapack, LLC \| Bausch Health Companies Inc.	2023-07-19	HUMAN PRESCRIPTION DRUG LABEL	53
Zegerid	Physicians Total Care, Inc.	2012-05-01	HUMAN PRESCRIPTION DRUG LABEL	1