Opioids in combination with non-opioid analgesics

Promethazine Hydrochloride and Codeine Phosphate

Approved 26 Aug 1997OralSyrup

The FDA lists this product in 8 strengths and forms.

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Composition

Active ingredients: CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SyrupThis page
CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SyrupANDA089647-001 · Discontinued
CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SyrupANDA200894-001 · Prescription
CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SyrupANDA090180-001 · Prescription
CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SyrupANDA200386-001 · Prescription
CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SyrupANDA088875-001 · Prescription
CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Syrup

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ANDA088763-001 · Discontinued

CODEINE PHOSPHATE 10MG/5ML; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SyrupANDA214238-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA040151.

Open Drugs@FDA

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Promethazine Hydrochloride and Codeine Phosphate
Active substance: codeine phosphate
Drug class: Opioids in combination with non-opioid analgesics, Opium alkaloids and derivatives
Group: Opioids
Route: Oral
Dosage form: Syrup
Applicant: Hikma
Status: Discontinued
FDA approval: 26 Aug 1997
Application: ANDA040151-001
RxCUI: 2672