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FDA Approval

Morphine Sulfate

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

FDA Approval Summary

Company

Physicians Total Care, Inc.

DUNS: 194123980

Effective Date

August 4, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(100 mg in 1 1)

Manufacturing Establishments1

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

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products4

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

54868-5590

Application Number

ANDA075295

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 7, 2011

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

Morphine Sulfate

Product Details

NDC Product Code

54868-4033

Application Number

ANDA075295

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 7, 2011

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

Morphine Sulfate

Product Details

NDC Product Code

54868-5054

Application Number

ANDA075295

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 7, 2011

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

Morphine Sulfate

Product Details

NDC Product Code

54868-5132

Application Number

ANDA075295

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 7, 2011

Ingredients

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1

HYPROMELLOSE 2208 (15000 MPA.S)Inactive

Code: Z78RG6M2N2Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

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