Omeprazole and Sodium Bicarbonate

Product NDC: 85509-1031
Requested package NDC: 85509-1031-3
11-digit product format: 855091031
Labeler code: 85509
Product ID: 85509-1031_3b2bf542-9d8a-6ff6-e063-6394a90a3fae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole and Sodium Bicarbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: PHOENIX RX LLC
Application: ANDA204228
Marketing category: ANDA
Marketing start: 2016-07-15
Substance: OMEPRAZOLE; SODIUM BICARBONATE
Active strength: 20; 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: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15
A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204228-001	AB
A204228-002	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	RS	2016-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204228-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204228-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-07-15	`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	A204228-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204228-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204228-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204228-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204228-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204228-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204228-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204228-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204228-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204228-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204228-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204228-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204228-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204228-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204228-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204228-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204228-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204228-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204228-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204228-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204228-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204228-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204228-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204228-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204228-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204228-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204228-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204228-002	AB	1	`74a2ff9319b5…`

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 and Sodium Bicarbonate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616539	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
3b2bf501-fd81-6ffa-e063-6394a90afe42	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	SPL version
85509-1031-1	Omeprazole and Sodium Bicarbonate	15 in 1 BOTTLE	CAPSULE	15	1
85509-1031-3	Omeprazole and Sodium Bicarbonate	30 in 1 BOTTLE	CAPSULE	30	1
85509-1031-6	Omeprazole and Sodium Bicarbonate	60 in 1 BOTTLE	CAPSULE	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85509-1031-1	EA - Each	85509-1031	1c3c07fd-bae7-409a-a397-74b9327daee3	1	2025-09-12
85509-1031-3	EA - Each	85509-1031	3436b33a-5611-438a-ba52-51e9ccd61caa	1	2025-09-12
85509-1031-6	EA - Each	85509-1031	8c060346-e9b5-4ba2-b1a5-e6beba9d6b35	1	2025-09-12

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Ajanta Pharma USA Inc.	cb657607-b038-47ee-b4e7-a5f419a14c33	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204228 application number: ANDA204228
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	PHOENIX RX LLC	3b2bf501-fd81-6ffa-e063-6394a90afe42	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204228 application number: ANDA204228 ndc (package): 85509-1031-3 ndc (product): 85509-1031 ndc11 (package): 85509103103
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	PHOENIX RX LLC	3b2cf6fd-72cb-fa53-e063-6394a90a674a	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204228 application number: ANDA204228
Omeprazole/Sodiium Bicarbonate	OMEPRAZOLE/SODIIUM BICARBONATE	Direct_rx	1f7f63c1-17c2-9a05-e063-6394a90abc6f	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204228 application number: ANDA204228

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	3b2bf501-fd81-6ffa-e063-6394a90afe42	1
616539	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule	SCD	3b2bf501-fd81-6ffa-e063-6394a90afe42	1
616539	Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule	SY	3b2bf501-fd81-6ffa-e063-6394a90afe42	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85509-1031-3	85509103103	30 CAPSULE in 1 BOTTLE (85509-1031-3)	30 capsule	2025-07-30	No	No	Current