FDA.reportPublic FDA data

Omeprazole

Product NDC
43598-286
11-digit product format
435980286
Labeler code
43598
Product ID
43598-286_ccd2bf38-c7b2-b12e-14a6-ca3631d9dfd4
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA207740
Marketing category
ANDA
Marketing start
2018-11-06
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-286-25Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE147
43598-286-25Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27
43598-286-27Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27
43598-286-32Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27
43598-286-33Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37
43598-286-37Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37
43598-286-37Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE147
43598-286-52Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
43598-286-70Omeprazole7 in 1 BLISTER PACKTABLET, DELAYED RELEASE77
43598-286-74Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE17
43598-286-74Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-286-33EA - Each43598-28642067ff0-a05a-4cf1-a797-5af13391fee412024-11-05
43598-286-52EA - Each43598-286df0c4c77-a812-44e6-add5-fb5148d2a50212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-286OMEPRAZOLE TABLET, DELAYED RELEASE [DR. REDDYS LABORATORIES INC]7Current NDC, Legacy NDC, 11 package rows20241222_4b3b389d-a151-d851-cb05-64eb49979e5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN4b3b389d-a151-d851-cb05-64eb49979e5e7
402014omeprazole 20 MG Delayed Release Oral TabletSCD4b3b389d-a151-d851-cb05-64eb49979e5e7
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY4b3b389d-a151-d851-cb05-64eb49979e5e7
402014omeprazole 20 MG Delayed Release Oral TabletPSN5e2994fc-8f44-f6e4-71fe-44a215aa93a93
402014omeprazole 20 MG Delayed Release Oral TabletSCD5e2994fc-8f44-f6e4-71fe-44a215aa93a93
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY5e2994fc-8f44-f6e4-71fe-44a215aa93a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-286-25435980286252 BLISTER PACK in 1 CARTON (43598-286-25) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2018-11-060000-00-00NoNoCurrent
43598-286-27435980286272 BOTTLE in 1 CARTON (43598-286-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) 2 bottle2018-11-060000-00-00NoNoCurrent
43598-286-32435980286322 BLISTER PACK in 1 CARTON (43598-286-32) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43598-286-70) 2 blister pack2018-11-060000-00-00NoNoCurrent
43598-286-33435980286333 BOTTLE in 1 CARTON (43598-286-33) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) 3 bottle2018-11-060000-00-00NoNoCurrent
43598-286-37435980286373 BLISTER PACK in 1 CARTON (43598-286-37) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 blister pack2018-11-060000-00-00NoNoCurrent
43598-286-524359802865214 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-286-52) 2018-11-060000-00-00NoNoCurrent
43598-286-70435980286707 in 1 BLISTER PACKHistorical
43598-286-74435980286741 BLISTER PACK in 1 CARTON (43598-286-74) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2018-11-060000-00-00NoNoCurrent
43598-286-86435980286863500 TABLET, DELAYED RELEASE in 1 POUCH (43598-286-86)06-NOV-18Current