Konvomep

Product NDC: 65628-272
Requested package NDC: 65628-272-10
11-digit product format: 656280272
Labeler code: 65628
Product ID: 65628-272_461e360d-0e63-e7b5-e063-6294a90a17c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole and sodium bicarbonate
Dosage form: KIT
Labeler: Azurity Pharmaceuticals, Inc.
Application: NDA213593
Marketing category: NDA
Marketing start: 2023-02-15
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213593-001	KONVOMEP	OMEPRAZOLE; SODIUM BICARBONATE	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL		RLD, RS	2022-08-30

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213593-001	10751333	2039-07-16		Drug product	2022-10-21
N213593-001	11103492	2039-07-16		Drug product	2022-10-21
N213593-001	11633478	2039-07-16		Drug product	2023-05-12
N213593-001	11911473	2039-07-16	U-623		2024-03-14
N213593-001	11911473	2039-07-16	U-624		2024-03-14
N213593-001	12042539	2039-07-16		Drug product	2024-08-02
N213593-001	12329752	2039-07-16		Drug product	2025-06-18
N213593-001	12440566	2039-07-16		Drug product	2025-10-15
N213593-001	11771686	2040-03-01	U-623		2023-10-30

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	12329752	2039-07-16		Drug product	2025-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	12440566	2039-07-16		Drug product	2025-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	12329752	2039-07-16		Drug product	2025-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	12440566	2039-07-16		Drug product	2025-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	12329752	2039-07-16		Drug product	2025-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Konvomep
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2625144	Internal RxNorm lookup
2625150	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
688ed6f1-d78a-4006-a682-57021cb38a3e	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
65628-270-03	Konvomep	90 mL in 1 BOTTLE	SUSPENSION	90 mL	2 mg in 1mL	6
65628-270-05	Konvomep	150 mL in 1 BOTTLE	SUSPENSION	150 mL	2 mg in 1mL	6
65628-270-10	Konvomep	300 mL in 1 BOTTLE	SUSPENSION	300 mL	2 mg in 1mL	6
65628-271-03	Konvomep	90 mL in 1 BOTTLE	SOLUTION	90 mL	84 mg in 1mL	6
65628-271-05	Konvomep	150 mL in 1 BOTTLE	SOLUTION	150 mL	84 mg in 1mL	6
65628-271-10	Konvomep	300 mL in 1 BOTTLE	SOLUTION	300 mL	84 mg in 1mL	6
65628-272-03	Konvomep	1 in 1 CARTON	KIT	1		6
65628-272-05	Konvomep	1 in 1 CARTON	KIT	1		6
65628-272-10	Konvomep	1 in 1 CARTON	KIT	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65628-272-03	ML - Milliliter	65628-272	70ce432a-40c1-47a9-943f-677600fd1aed	1	2023-03-13
65628-272-05	ML - Milliliter	65628-272	2c976a49-6f1d-4cf5-9280-8d65b86d71af	1	2023-03-13
65628-272-10	ML - Milliliter	65628-272	dad4d756-b9b1-4fd2-84b0-9637c1148694	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65628-272	KONVOMEP (OMEPRAZOLE AND SODIUM BICARBONATE) KIT [AZURITY PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 9 package rows	20241208_688ed6f1-d78a-4006-a682-57021cb38a3e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Konvomep	OMEPRAZOLE AND SODIUM BICARBONATE	Azurity Pharmaceuticals, Inc.	688ed6f1-d78a-4006-a682-57021cb38a3e	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213593 application number: NDA213593 ndc (package): 65628-272-10 ndc (product): 65628-272 ndc11 (package): 65628027210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2625150	KONVOMEP 2 MG / 84 MG in 1 mL Oral Suspension	PSN	688ed6f1-d78a-4006-a682-57021cb38a3e	6
2625144	omeprazole 2 MG/mL / sodium bicarbonate 84 MG/mL Oral Suspension	PSN	688ed6f1-d78a-4006-a682-57021cb38a3e	6
2625150	omeprazole 2 MG/ML / sodium bicarbonate 84 MG/ML Oral Suspension [Konvomep]	SBD	688ed6f1-d78a-4006-a682-57021cb38a3e	6
2625144	omeprazole 2 MG/ML / sodium bicarbonate 84 MG/ML Oral Suspension	SCD	688ed6f1-d78a-4006-a682-57021cb38a3e	6
2625150	Konvomep (omeprazole 2 MG/ML / sodium bicarbonate 84 MG/ML) Oral Suspension	SY	688ed6f1-d78a-4006-a682-57021cb38a3e	6
2625144	omeprazole 2 MG/ML / NaHCO3 84 MG/ML Oral Suspension	SY	688ed6f1-d78a-4006-a682-57021cb38a3e	6
2625150	omeprazole 2 MG/ML / NaHCO3 84 MG/ML Oral Suspension [Konvomep]	SY	688ed6f1-d78a-4006-a682-57021cb38a3e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65628-272-10	65628027210	1 KIT in 1 CARTON (65628-272-10) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03)	1 kit	2023-02-15	0000-00-00	No	No	Current