Morphine Sulfate

Manufacturing Establishments1

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

Labeler

PAI Holdings, LLC

DUNS Number

097630693

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

NDC Product Code

0121-0825

Application Number

ANDA206573

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 4, 2023

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 5 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT