Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Astrazeneca Limited Partnership
785395237
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ranbaxy Pharmaceuticals Inc
Ranbaxy Laboratories Inc.
Astrazeneca Limited Partnership
937890044
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omeprazole Delayed-Release
Product Details
NDC Product Code
63304-445Application Number
NDA019810Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
August 25, 2009OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1 1
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
FERRIC OXIDEInactive
Code: 1K09F3G675Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT