promethazine hydrochloride and dextromethorphan hydrobromide

Generic: promethazine hydrochloride and dextromethorphan hydrobromide

Labeler: cranbury pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and dextromethorphan hydrobromide
Generic Name promethazine hydrochloride and dextromethorphan hydrobromide
Labeler cranbury pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 15 mg/5mL, promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-057
Product ID 27808-057_c48beb7d-69be-4ace-82b1-d1a1210b7f32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091687
Marketing Start 2014-01-31
Marketing End 2027-04-01

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808057
Hyphenated Format 27808-057

Supplemental Identifiers

RxCUI
991528
UPC
0327808057013
UNII
9D2RTI9KYH 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 dextromethorphan hydrobromide (source: ndc)
Generic Name promethazine hydrochloride and dextromethorphan hydrobromide (source: ndc)
Application Number ANDA091687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
  • 6.25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (27808-057-01)
source: ndc

Packages (1)

27808-057-01 473 mL in 1 BOTTLE, PLASTIC (27808-057-01)

Ingredients (2)

dextromethorphan hydrobromide (15 mg/5mL) promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

Promethazine Hydrochloride and Dextromethorphan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c48beb7d-69be-4ace-82b1-d1a1210b7f32", "openfda": {"upc": ["0327808057013"], "unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (27808-057-01)", "package_ndc": "27808-057-01", "marketing_end_date": "20270401", "marketing_start_date": "20211115"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "27808-057_c48beb7d-69be-4ace-82b1-d1a1210b7f32", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "27808-057", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "Cranbury Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA091687", "marketing_category": "ANDA", "marketing_end_date": "20270401", "marketing_start_date": "20140131"}