United States · FDA National Drug Code directory
PROMETHAZINE HYDROCHLORIDE
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
- 0116-4023_302bfe23-7984-140e-e063-6394a90acad1
- Product NDC
- 0116-4023
- Form
- SYRUP
- Composition / generic term
- promethazine hydrochloride
- 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
These values do not establish equivalence or a dose recommendation.
Packages
- 473 mL in 1 BOTTLE, PLASTIC (0116-4023-16) · 0116-4023-16
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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