MedPath
FDA Product

Promethazine with Codeine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Promethazine with Codeine

67296-0516

Regulatory Information

67296-0516

ANDA088875

C73584

January 1, 2021

USA

PROMETHAZINE WITH CODEINE ORAL SOLUTION

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

828374897

Active Ingredients

TRISODIUM CITRATE DIHYDRATE

Code: B22547B95K

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

ASCORBIC ACID

Code: PQ6CK8PD0R

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

D&C RED NO. 33

Code: 9DBA0SBB0L

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

PROMETHAZINE HYDROCHLORIDE

Quantity: 6.25 mg in 5 mL

Code: R61ZEH7I1I

Class Code: ACTIB

CODEINE PHOSPHATE

Quantity: 10 mg in 5 mL

Code: GSL05Y1MN6

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM PROPIONATE ANHYDROUS

Code: 391O0PO49R

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

CODEINE ANHYDROUS

Code: UX6OWY2V7J

PROMETHAZINE

Code: FF28EJQ494

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