Omeprazole/Sodium Bicarbonate

Product NDC: 49884-268
Requested package NDC: 49884-268-11
11-digit product format: 498840268
Labeler code: 49884
Product ID: 49884-268_d01c3df2-2286-4a20-bbdb-939148dd30dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole and Sodium Bicarbonate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA079182
Marketing category: ANDA
Marketing start: 2016-07-18
Marketing end: 0000-00-00
Substance: OMEPRAZOLE; SODIUM BICARBONATE
Active strength: 20 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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49884-268	49884-268-11	D	Discontinued by firm		2026-08-03

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

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

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
A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB		2013-04-19
A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB		2013-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A079182-001	AB
A079182-002	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 3 · 82 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	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A079182-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079182-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079182-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079182-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079182-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079182-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079182-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079182-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079182-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079182-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079182-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079182-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079182-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079182-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079182-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079182-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079182-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079182-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079182-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079182-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079182-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079182-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079182-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079182-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079182-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079182-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079182-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079182-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079182-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079182-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079182-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079182-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079182-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079182-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079182-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079182-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079182-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079182-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079182-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079182-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49884-268-11	2022-09-27	C162847	48780-1	e4f33bdf-ade9-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION. OMEPRAZOLE AND SODIUM BICARBONATE, for oral suspension Initial U.S. Approval: 2004
49884-268-11	2022-07-29	C162847	48780-1	e4f33bdf-ade9-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION. OMEPRAZOLE AND SODIUM BICARBONATE, for oral suspension Initial U.S. Approval: 2004

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole/Sodium Bicarbonate	OMEPRAZOLE	Strides Pharma Science Limited	cf6d293e-d70d-443e-8292-d693e93aab55	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079182 application number: ANDA079182

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-268-11	49884026811	30 PACKET in 1 CARTON (49884-268-11) > 1 POWDER, FOR SUSPENSION in 1 PACKET (49884-268-52)	30 packet	2016-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole/Sodium Bicarbonate	Bryant Ranch Prepack	2022-04-20	HUMAN PRESCRIPTION DRUG LABEL	101
Omeprazole/Sodium Bicarbonate	Par Pharmaceutical, Inc. \| Par Pharmaceutical Inc.	2020-07-28	HUMAN PRESCRIPTION DRUG LABEL	14