promethazine hydrochloride and codeine phosphate (72162-2042)

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and codeine phosphate

Generic Name promethazine hydrochloride and codeine phosphate

Labeler bryant ranch prepack

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

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

Manufacturer

Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2042

Product ID 72162-2042_14f5be0d-d8f8-4a3f-bfee-5d0a628361d7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA200386

DEA Schedule cv

Listing Expiration 2026-12-31

Marketing Start 2018-03-12

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 721622042

Hyphenated Format 72162-2042

Supplemental Identifiers

RxCUI

991486

UNII

GSL05Y1MN6 R61ZEH7I1I

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 ANDA200386 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/5mL
6.25 mg/5mL

source: ndc

Packaging

473 mL in 1 BOTTLE, PLASTIC (72162-2042-2)

source: ndc

Packages (1)

72162-2042-2 473 mL in 1 BOTTLE, PLASTIC (72162-2042-2)

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": "14f5be0d-d8f8-4a3f-bfee-5d0a628361d7", "openfda": {"unii": ["GSL05Y1MN6", "R61ZEH7I1I"], "rxcui": ["991486"], "spl_set_id": ["df2c24ba-1c88-4ec3-b2a1-801358ec645c"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (72162-2042-2)", "package_ndc": "72162-2042-2", "marketing_start_date": "20180312"}], "brand_name": "Promethazine Hydrochloride and Codeine Phosphate", "product_id": "72162-2042_14f5be0d-d8f8-4a3f-bfee-5d0a628361d7", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]", "Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "72162-2042", "dea_schedule": "CV", "generic_name": "Promethazine Hydrochloride and Codeine Phosphate", "labeler_name": "Bryant Ranch Prepack", "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": "ANDA200386", "marketing_category": "ANDA", "marketing_start_date": "20180312", "listing_expiration_date": "20261231"}