Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Quality Care Products LLC
Quality Care Products LLC
831276758
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
55700-349Application Number
ANDA202104Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 12, 2018MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 1 1
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
ethylcellulosesInactive
Code: 7Z8S9VYZ4BClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
diethyl phthalateInactive
Code: UF064M00AFClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
gelatinInactive
Code: 2G86QN327LClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3GClass: IACT