promethazine dm

Generic: promethazine hydrochloride and dextromethorphan hydrobromide

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine dm
Generic Name promethazine hydrochloride and dextromethorphan hydrobromide
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1070
Product ID 0121-1070_acf1463f-bbbe-42e9-9b06-a306e95a4325
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040649
Listing Expiration 2026-12-31
Marketing Start 2025-06-04

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 01211070
Hyphenated Format 0121-1070

Supplemental Identifiers

RxCUI
991528
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 dm (source: ndc)
Generic Name promethazine hydrochloride and dextromethorphan hydrobromide (source: ndc)
Application Number ANDA040649 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
  • 6.25 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (0121-1070-04)
  • 473 mL in 1 BOTTLE (0121-1070-16)
source: ndc

Packages (2)

0121-1070-04 118 mL in 1 BOTTLE (0121-1070-04) 0121-1070-16 473 mL in 1 BOTTLE (0121-1070-16)

Ingredients (2)

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

Linked Drug Pages (1)

Promethazine DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "acf1463f-bbbe-42e9-9b06-a306e95a4325", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["1d47280d-28c9-4701-8c5f-a6e6b524083b"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (0121-1070-04)", "package_ndc": "0121-1070-04", "marketing_start_date": "20250604"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-1070-16)", "package_ndc": "0121-1070-16", "marketing_start_date": "20250604"}], "brand_name": "Promethazine DM", "product_id": "0121-1070_acf1463f-bbbe-42e9-9b06-a306e95a4325", "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": "0121-1070", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040649", "marketing_category": "ANDA", "marketing_start_date": "20250604", "listing_expiration_date": "20261231"}