FDA.reportPublic FDA data

Konvomep

Product NDC
65628-272
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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2625144, 2625150

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65628-270-03Konvomep90 mL in 1 BOTTLESUSPENSION90 mL2 mg in 1mL6
65628-270-05Konvomep150 mL in 1 BOTTLESUSPENSION150 mL2 mg in 1mL6
65628-270-10Konvomep300 mL in 1 BOTTLESUSPENSION300 mL2 mg in 1mL6
65628-271-03Konvomep90 mL in 1 BOTTLESOLUTION90 mL84 mg in 1mL6
65628-271-05Konvomep150 mL in 1 BOTTLESOLUTION150 mL84 mg in 1mL6
65628-271-10Konvomep300 mL in 1 BOTTLESOLUTION300 mL84 mg in 1mL6
65628-272-03Konvomep1 in 1 CARTONKIT16
65628-272-05Konvomep1 in 1 CARTONKIT16
65628-272-10Konvomep1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65628-272-03ML - Milliliter65628-27270ce432a-40c1-47a9-943f-677600fd1aed12023-03-13
65628-272-05ML - Milliliter65628-2722c976a49-6f1d-4cf5-9280-8d65b86d71af12023-03-13
65628-272-10ML - Milliliter65628-272dad4d756-b9b1-4fd2-84b0-9637c114869412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65628-272KONVOMEP (OMEPRAZOLE AND SODIUM BICARBONATE) KIT [AZURITY PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 9 package rows20241208_688ed6f1-d78a-4006-a682-57021cb38a3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2625150KONVOMEP 2 MG / 84 MG in 1 mL Oral SuspensionPSN688ed6f1-d78a-4006-a682-57021cb38a3e6
2625144omeprazole 2 MG/mL / sodium bicarbonate 84 MG/mL Oral SuspensionPSN688ed6f1-d78a-4006-a682-57021cb38a3e6
2625150omeprazole 2 MG/ML / sodium bicarbonate 84 MG/ML Oral Suspension [Konvomep]SBD688ed6f1-d78a-4006-a682-57021cb38a3e6
2625144omeprazole 2 MG/ML / sodium bicarbonate 84 MG/ML Oral SuspensionSCD688ed6f1-d78a-4006-a682-57021cb38a3e6
2625150Konvomep (omeprazole 2 MG/ML / sodium bicarbonate 84 MG/ML) Oral SuspensionSY688ed6f1-d78a-4006-a682-57021cb38a3e6
2625144omeprazole 2 MG/ML / NaHCO3 84 MG/ML Oral SuspensionSY688ed6f1-d78a-4006-a682-57021cb38a3e6
2625150omeprazole 2 MG/ML / NaHCO3 84 MG/ML Oral Suspension [Konvomep]SY688ed6f1-d78a-4006-a682-57021cb38a3e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65628-270-036562802700390 mL in 1 BOTTLE90 mlHistorical
65628-270-0565628027005150 mL in 1 BOTTLE150 mlHistorical
65628-270-1065628027010300 mL in 1 BOTTLE300 mlHistorical
65628-271-036562802710390 mL in 1 BOTTLE90 mlHistorical
65628-271-0565628027105150 mL in 1 BOTTLE150 mlHistorical
65628-271-1065628027110300 mL in 1 BOTTLE300 mlHistorical
65628-272-03656280272031 KIT in 1 CARTON (65628-272-03) * 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 kit2023-02-150000-00-00NoNoCurrent
65628-272-05656280272051 KIT in 1 CARTON (65628-272-05) * 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 kit2023-02-150000-00-00NoNoCurrent
65628-272-10656280272101 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 kit2023-02-150000-00-00NoNoCurrent