FDA.reportPublic FDA data

NDC 73377-083 - Dexmedetomidine HCl

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
73377-083
Package NDCs from labels
73377-083-01, 73377-083-02
Manufacturer
AX Pharmaceutical Corp
Effective date
2023-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexmedetomidine HCl - AX Pharmaceutical CorpAX Pharmaceutical Corp2023-02-02BULK INGREDIENT - ANIMAL DRUG

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.809e8f77-390f-4cc8-8c8a-4f67a249c9df2026-09-08Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEAvenacy Inc.eee6145b-d83f-4596-92d3-733934d8a3a42026-08-05Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DEXMEDETOMIDINEDEXMEDETOMIDINEMeitheal Pharmaceuticals Inc.8fa36783-b94d-4084-8c41-40ee641920742026-08-03Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEPiramal Critical Care Incc958aeb4-69ce-c3e2-e053-2a95a90a6d8d2026-07-28Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEEugia US LLC8c162541-986b-4b30-866c-b2631ba2c9752026-07-20Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEPiramal Critical Care Incc116d83f-35da-19ca-e053-2a95a90a017d2026-06-26Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.92b7ddaa-e45a-4b64-a802-bb5df8771dd62026-06-17Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.4419162d-81d4-49bd-96de-1729440bdb742026-06-09Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEPiramal Critical Care Incb93a71ed-0f9e-1ff9-e053-2995a90a789d2026-06-03Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare Corporation7d057255-22a1-4b69-ad7c-7337fac8e9932026-05-29Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEAmneal Pharmaceuticals LLCeb1ba463-ab42-4f49-9ebe-3ad5af1083262026-05-28Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDECIVICA, INC.1faf1ac8-ff9b-4ed9-b562-06dab971173a2026-05-22Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDEHenry Schein, Inc.9eb336de-5fa5-4b46-b40b-a7ca5a0864bd2026-05-21Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEGland Pharma Limitedf307de7e-a9ab-4734-abb7-66b4e112bc512026-05-20Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.548a88c0-afda-427e-75ac-5af0cfa2224c2026-05-20Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEMylan Institutional LLCf140de5a-f13d-46b4-a742-049c63e474f52026-05-20Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDEAmneal Pharmaceuticals LLC4df8cc35-fc80-4438-b982-9c4b7d17bad22026-05-19Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEGland Pharma Limited714cc0d2-8a4c-40c0-8ef0-dcfde4c469892026-05-19Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEMylan Institutional LLCebdfe2e8-30ca-4f18-935a-41bcbbce49372026-05-18Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEFresenius Kabi USA, LLC1896a96e-25f8-494e-9a96-6463b52fb1022026-01-23Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.