Application 079182

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	FOR SUSPENSION;ORAL	20MG/PACKET;1.68GM/PACKET	No	No
002	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	FOR SUSPENSION;ORAL	40MG/PACKET;1.68GM/PACKET	No	No

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

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 · 86 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	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079182-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079182-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	2013-04-19	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A079182-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079182-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079182-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079182-002	AB	1	`caaa826d4ba7…`
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…`

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 ndc (product): 64380-183 ndc (product): 64380-182

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-268	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Par Pharmaceutical, Inc.	ANDA	Current
49884-268	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Par Pharmaceutical, Inc.	ANDA	Current
49884-268	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Par Pharmaceutical, Inc.	ANDA	Current
49884-268	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Par Pharmaceutical, Inc.	ANDA	Current
49884-269	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Par Pharmaceutical, Inc.	ANDA	Current
49884-269	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Par Pharmaceutical, Inc.	ANDA	Current
49884-269	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Par Pharmaceutical, Inc.	ANDA	Current
49884-269	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Par Pharmaceutical, Inc.	ANDA	Current
63629-2242	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Bryant Ranch Prepack	ANDA	Current
63629-2242	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Bryant Ranch Prepack	ANDA	Current
63629-2243	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Bryant Ranch Prepack	ANDA	Current
63629-2243	Omeprazole/Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	Bryant Ranch Prepack	ANDA	Current
64380-182	Omeprazole/Sodium Bicarbonate	omeprazole	Strides Pharma Science Limited	ANDA	Current
64380-183	Omeprazole/Sodium Bicarbonate	omeprazole	Strides Pharma Science Limited	ANDA	Current