promethazine hydrochloride and codeine phosphate (70752-139)

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and codeine phosphate

Generic Name promethazine hydrochloride and codeine phosphate

Labeler quagen pharmaceuticals llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

codeine phosphate 10 mg/5mL, promethazine hydrochloride 6.25 mg/5mL

Manufacturer

QUAGEN PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 70752-139

Product ID 70752-139_ea7f15a6-079d-4146-a13d-74c129ec598e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214238

DEA Schedule cv

Listing Expiration 2026-12-31

Marketing Start 2020-10-08

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc] phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70752139

Hyphenated Format 70752-139

Supplemental Identifiers

RxCUI

991486

UPC

0370752139120

UNII

GSL05Y1MN6 R61ZEH7I1I

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name promethazine hydrochloride and codeine phosphate (source: ndc)

Generic Name promethazine hydrochloride and codeine phosphate (source: ndc)

Application Number ANDA214238 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/5mL
6.25 mg/5mL

source: ndc

Packaging

118 mL in 1 BOTTLE, PLASTIC (70752-139-06)
473 mL in 1 BOTTLE, PLASTIC (70752-139-12)

source: ndc

Packages (2)

70752-139-06 118 mL in 1 BOTTLE, PLASTIC (70752-139-06) 70752-139-12 473 mL in 1 BOTTLE, PLASTIC (70752-139-12)

Ingredients (2)

codeine phosphate (10 mg/5mL) promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

Promethazine Hydrochloride and Codeine Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ea7f15a6-079d-4146-a13d-74c129ec598e", "openfda": {"upc": ["0370752139120"], "unii": ["GSL05Y1MN6", "R61ZEH7I1I"], "rxcui": ["991486"], "spl_set_id": ["9aca56ec-28f8-4679-9f90-ec3e82deb9ac"], "manufacturer_name": ["QUAGEN PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (70752-139-06)", "package_ndc": "70752-139-06", "marketing_start_date": "20201008"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (70752-139-12)", "package_ndc": "70752-139-12", "marketing_start_date": "20201008"}], "brand_name": "Promethazine Hydrochloride and Codeine Phosphate", "product_id": "70752-139_ea7f15a6-079d-4146-a13d-74c129ec598e", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]", "Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "70752-139", "dea_schedule": "CV", "generic_name": "Promethazine Hydrochloride and Codeine Phosphate", "labeler_name": "QUAGEN PHARMACEUTICALS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Codeine Phosphate", "active_ingredients": [{"name": "CODEINE PHOSPHATE", "strength": "10 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA214238", "marketing_category": "ANDA", "marketing_start_date": "20201008", "listing_expiration_date": "20261231"}