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: 0116-4024_30c9dc19-5091-17dd-e063-6394a90a51f9
Product NDC: 0116-4024
Form: SYRUP
Composition / generic term: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Labeler: Xttrium Laboratories, Inc
Marketing category: ANDA
Marketing start / end (source format): 20250407
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

473 mL in 1 BOTTLE, PLASTIC (0116-4024-16) · 0116-4024-16

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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