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
0121-1854_628c0c05-9610-4a8e-ae9b-f6aad47993d6
Product NDC
0121-1854
Form
SOLUTION
Composition / generic term
Promethazine Hydrochloride
Labeler
PAI Holdings, LLC dba PAI Pharma
Marketing category
ANDA
Marketing start / end (source format)
20250807
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 (0121-1854-16) · 0121-1854-16

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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