MedPath
FDA Approval

Morphine Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Rhodes Pharmaceuticals L. P.
DUNS: 831928986
Effective Date
January 18, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Morphine(60 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Rhodes Pharmaceuticals L. P.

831928986

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Purdue Pharmaceuticals L.P.

Rhodes Pharmaceuticals L. P.

Rhodes Pharmaceuticals L. P.

132080875

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Morphine Sulfate Extended Release

Product Details

NDC Product Code
42858-803
Application Number
ANDA074862
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 31, 2023
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT

Morphine Sulfate Extended Release

Product Details

NDC Product Code
42858-802
Application Number
ANDA074862
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 31, 2023
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT

Morphine Sulfate Extended Release

Product Details

NDC Product Code
42858-804
Application Number
ANDA074769
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 31, 2023
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT

Morphine Sulfate Extended Release

Product Details

NDC Product Code
42858-805
Application Number
ANDA074769
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 31, 2023
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 200 mg in 1 1
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT

Morphine Sulfate Extended Release

Product Details

NDC Product Code
42858-801
Application Number
ANDA074862
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 31, 2023
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy