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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

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Effective Date

December 14, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(30 mg in 1 1)

Registrants1

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

Sun Pharmaceutical Industries, Inc.

DUNS Number

146974886

Manufacturing Establishments2

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

Labeler

Sun Pharmaceutical Industries, Inc.

Registrant

Sun Pharmaceutical Industries, Inc.

DUNS Number

166506142

Ohm Laboratories Inc.

Labeler

Sun Pharmaceutical Industries, Inc.

Registrant

Sun Pharmaceutical Industries, Inc.

DUNS Number

184769029

Products5

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

63304-451

Application Number

ANDA078761

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 14, 2023

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

Morphine sulfate

Product Details

NDC Product Code

63304-450

Application Number

ANDA078761

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 14, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95Class: IACT

Morphine sulfate

Product Details

NDC Product Code

63304-452

Application Number

ANDA078761

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 14, 2023

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

Morphine sulfate

Product Details

NDC Product Code

63304-758

Application Number

ANDA078761

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 14, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95Class: IACT

Morphine sulfate

Product Details

NDC Product Code

63304-453

Application Number

ANDA078761

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 14, 2023

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 200 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

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