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Zimhi 1

by Zmi Pharma GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00384571140021 UDI-DIDate16 Jan 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Zimhi
Generic Name
Prefilled syringe/needle
Model / Reference
1
Description
ZIMHI® (naloxone HCl Injection, USP) 5 mg/0.5 mL FOR INTERMUSCULAR OR SUBCUTANEOUS INJECTION
Primary DI / UDI-DI
00384571140021
FDA Product Code
FMF
GMDN Term
Prefilled syringe/needle
Device Class
Class II
Regulation Number
880.5860
Commercial Distribution
In Commercial Distribution

Properties

  • Single Use
  • Prescription Use
  • Combination Product
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No