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.
Dispensing Solutions, Inc.
Dispensing Solutions, Inc.
PSS World Medical, Inc.
066070785
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
66336-502Application Number
NDA022207Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 8, 2013STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT