promethazine hydrochloride and dextromethorphan hydrobromide

Generic: promethazine hydrochloride and dextromethorphan hydrobromide

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and dextromethorphan hydrobromide
Generic Name promethazine hydrochloride and dextromethorphan hydrobromide
Labeler ani pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-758
Product ID 62559-758_d9ff674c-ec90-4e98-9d7e-cfab92649343
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA011265
Listing Expiration 2026-12-31
Marketing Start 2024-09-05

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 62559758
Hyphenated Format 62559-758

Supplemental Identifiers

RxCUI
991528
UPC
0362559758048
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 NDA011265 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
  • 6.25 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (62559-758-04)
  • 473 mL in 1 BOTTLE (62559-758-16)
source: ndc

Packages (2)

62559-758-04 118 mL in 1 BOTTLE (62559-758-04) 62559-758-16 473 mL in 1 BOTTLE (62559-758-16)

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": "d9ff674c-ec90-4e98-9d7e-cfab92649343", "openfda": {"upc": ["0362559758048"], "unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["a52e210f-b99d-493e-b679-ec565c6ff72d"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (62559-758-04)", "package_ndc": "62559-758-04", "marketing_start_date": "20240905"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62559-758-16)", "package_ndc": "62559-758-16", "marketing_start_date": "20240905"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "62559-758_d9ff674c-ec90-4e98-9d7e-cfab92649343", "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": "62559-758", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "ANI Pharmaceuticals, Inc.", "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": "NDA011265", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240905", "listing_expiration_date": "20261231"}