United States · FDA National Drug Code directory
Amiodarone 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
- 72078-046_7cfc7c84-7d98-4060-bb6c-8268244be3cb
- Product NDC
- 72078-046
- Form
- INJECTION, SOLUTION
- Composition / generic term
- amiodarone hydrochloride
- Labeler
- Mylan Institutional LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20230609
- Source listing expiry
- 20261231
Source-listed ingredients
- AMIODARONE HYDROCHLORIDE — 50 mg/mL
These values do not establish equivalence or a dose recommendation.
Packages
- 10 VIAL, GLASS in 1 CARTON (72078-046-09) / 9 mL in 1 VIAL, GLASS (72078-046-00) · 72078-046-09
- 1 VIAL, GLASS in 1 CARTON (72078-046-18) / 18 mL in 1 VIAL, GLASS · 72078-046-18
Source and coverage
Open FDA National Drug Code directory →
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.
Browse United States records →