PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Product NDC

0121-0547

11-digit product format

001210547

Labeler code

0121

Product ID

0121-0547_f42373cd-3894-4b6f-8995-c45f96e931cb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Dosage form

SYRUP

Route

ORAL

Labeler

Pharmaceutical Associates, Inc.

Application

ANDA089647

Marketing category

ANDA

Marketing start

1988-12-22

Marketing end

0000-00-00

Substance

PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE

Active strength

6 mg/5mL; mg/5mL

Pharmacologic classes

Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]

DEA schedule

CV

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record