Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical Inc.
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
STAT Rx USA LLC
STAT Rx USA LLC
PSS World Medical Inc.
786036330
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MORPHINE SULFATE
Product Details
NDC Product Code
16590-966Application Number
ANDA074862Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2012MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT