promethazine hydrochloride and codeine phosphate

Generic: promethazine hydrochloride and codeine phosphate

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and codeine phosphate
Generic Name promethazine hydrochloride and codeine phosphate
Labeler cosette pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0823
Product ID 0713-0823_ad6f539c-d968-4a3b-9550-ab7e78bee74c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200386
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-12-19

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 07130823
Hyphenated Format 0713-0823

Supplemental Identifiers

RxCUI
991486
UPC
0307130823753
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 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 (0713-0823-75)
source: ndc

Packages (1)

0713-0823-75 473 mL in 1 BOTTLE, PLASTIC (0713-0823-75)

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": "ad6f539c-d968-4a3b-9550-ab7e78bee74c", "openfda": {"upc": ["0307130823753"], "unii": ["GSL05Y1MN6", "R61ZEH7I1I"], "rxcui": ["991486"], "spl_set_id": ["3b02cda4-9b24-79c9-e063-6294a90af5b9"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0713-0823-75)", "package_ndc": "0713-0823-75", "marketing_start_date": "20251219"}], "brand_name": "Promethazine Hydrochloride and Codeine Phosphate", "product_id": "0713-0823_ad6f539c-d968-4a3b-9550-ab7e78bee74c", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]", "Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0713-0823", "dea_schedule": "CV", "generic_name": "Promethazine Hydrochloride and Codeine Phosphate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "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": "20251219", "listing_expiration_date": "20261231"}