Dexmedetomidine

Product NDC
71872-7150
11-digit product format
718727150
Labeler code
71872
Product ID
71872-7150_81a1df0e-89b4-e13d-e053-2991aa0a4db4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC.
Application
ANDA209065
Marketing category
ANDA
Marketing start
2018-03-01
Marketing end
0000-00-00
Substance
DEXMEDETOMIDINE HYDROCHLORIDE
Active strength
100 ug/mL
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71872-7150DDiscontinued by firm2026-08-10
excluded packagepackage71872-715071872-7150-1DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71872-7150-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71872-7150-1f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209065-001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTION2017-09-19
A209065-002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12
A209065-003DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12
A209065-004DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209065-002AP
A209065-003AP
A209065-004AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209065-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2017-09-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A209065-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A209065-003DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A209065-004DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-12d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 151 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209065-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209065-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209065-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209065-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209065-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209065-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209065-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209065-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209065-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209065-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209065-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209065-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209065-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209065-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209065-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209065-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209065-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209065-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209065-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209065-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209065-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209065-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209065-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209065-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209065-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209065-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209065-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209065-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209065-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209065-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209065-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209065-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209065-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209065-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209065-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209065-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209065-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209065-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209065-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209065-004AP1d06236e962d9…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7150DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE [MEDICAL PURCHASING SOLUTIONS, LLC.]2Legacy NDC20230517_81a1df0e-89b3-e13d-e053-2991aa0a4db4.zip

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexmedetomidineDEXMEDETOMIDINEAvenacy Inc.eee6145b-d83f-4596-92d3-733934d8a3a42026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209065
application number: ANDA209065
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEProPharma Distribution42caba25-dd87-040c-e063-6294a90a7a122025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209065
application number: ANDA209065
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.809e8f77-390f-4cc8-8c8a-4f67a249c9df2023-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209065
application number: ANDA209065

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7150-1718727150011 VIAL in 1 BAG (71872-7150-1) > 2 mL in 1 VIAL1 vial2019-01-080000-00-00NoNoCurrent