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
65841-040_800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5
Product NDC
65841-040
Form
TABLET
Composition / generic term
Promethazine Hydrochloride
Labeler
Zydus Lifesciences Limited
Marketing category
ANDA
Marketing start / end (source format)
20051214
Source listing expiry
20261231

Source-listed ingredients

  • PROMETHAZINE HYDROCHLORIDE — 12.5 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 100 TABLET in 1 BOTTLE (65841-040-01) · 65841-040-01
  • 500 TABLET in 1 BOTTLE (65841-040-05) · 65841-040-05
  • 1000 TABLET in 1 BOTTLE (65841-040-10) · 65841-040-10

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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