Not Applicable

Product NDC: 69336-112
11-digit product format: 693360112
Labeler code: 69336
Product ID: 69336-112_871465bc-55d1-4b4e-97d9-8591d705d78c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole sodium bicarbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: Sterling Knight Pharmaceuticals LLC
Application: ANDA207476
Marketing category: ANDA
Marketing start: 2017-07-13
Marketing end: 0000-00-00
Substance: OMEPRAZOLE; SODIUM BICARBONATE
Active strength: 40 mg/1; mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69336-112		I	Inactivated by FDA		2026-10-12
excluded package	package	69336-112	69336-112-30	I	Inactivated by FDA		2026-10-12

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69336-112-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69336-112-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69336-112-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69336-112-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69336-112-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69336-112-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69336-112-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69336-112-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69336-112-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69336-112-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69336-112-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69336-112-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69336-112-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69336-112-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69336-112-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69336-112-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69336-112-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69336-112-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69336-112-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69336-112-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69336-112-30	`9bebd1f3094a…`	`5416666fcb17…`

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
A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB		2016-12-06
A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB		2016-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207476-001	AB
A207476-002	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	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207476-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207476-002	OMEPRAZOLE AND SODIUM BICARBONATE	40MG;1.1GM	CAPSULE / ORAL	AB	2016-12-06	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A207476-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207476-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207476-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207476-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207476-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207476-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207476-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207476-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207476-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207476-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207476-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207476-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207476-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207476-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207476-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207476-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207476-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207476-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207476-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207476-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207476-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207476-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207476-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207476-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207476-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207476-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207476-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207476-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207476-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207476-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207476-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207476-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207476-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207476-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207476-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207476-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207476-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207476-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207476-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207476-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
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
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873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
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0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
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89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69336-112-30	2020-01-31	C162847	48780-1	9d75b9d0-5fd7-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES.OMEPRAZOLE and SODIUM BICARBONATE capsules, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69336-112-30	Not Applicable	30 in 1 PACKAGE	CAPSULE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69336-112-30	EA - Each	69336-112	0af5e33d-e1f7-41fa-b1d5-b5dbf9adaefd	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69336-112	NOT APPLICABLE (OMEPRAZOLE SODIUM BICARBONATE) CAPSULE [STERLING KNIGHT PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20170714_f77428fd-1744-4b3f-bd9c-b7fde46a211a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole/Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Proficient Rx LP	4d642036-7175-4f29-9f07-dbd282231d4a	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207476 application number: ANDA207476
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	ScieGen Pharmaceuticals, Inc.	a107804e-b308-4e79-9447-07d93016f70f	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207476 application number: ANDA207476
omeprazole sodium bicarbonate	OMEPRAZOLE SODIUM BICARBONATE	Cipla USA Inc.	9cdde58a-ae8a-451f-92cf-cab178e4ba92	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207476 application number: ANDA207476

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
616541	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule	PSN	f77428fd-1744-4b3f-bd9c-b7fde46a211a	1
616541	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule	SCD	f77428fd-1744-4b3f-bd9c-b7fde46a211a	1
616541	Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule	SY	f77428fd-1744-4b3f-bd9c-b7fde46a211a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69336-112-30	69336011230	30 in 1 PACKAGE	Historical