United States · FDA National Drug Code directory

Promethazine Hydrochloride and Dextromethorphan Hydrobromide

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
62559-758_d9ff674c-ec90-4e98-9d7e-cfab92649343
Product NDC
62559-758
Form
SOLUTION
Composition / generic term
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Labeler
ANI Pharmaceuticals, Inc.
Marketing category
NDA AUTHORIZED GENERIC
Marketing start / end (source format)
20240905
Source listing expiry
20261231

Source-listed ingredients

  • PROMETHAZINE HYDROCHLORIDE — 6.25 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE — 15 mg/5mL

These values do not establish equivalence or a dose recommendation.

Packages

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

Source and coverage

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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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