Dexmedetomidine Hydrochloride

Product NDC
65219-642
11-digit product format
652190642
Labeler code
65219
Product ID
65219-642_1896a96e-25f8-494e-9a96-6463b52fb102
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA201072
Marketing category
ANDA
Marketing start
2015-09-18
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201072-001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201072-001AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-183f01610625f2…
2019-09-15 20:21 UTC2019-09A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201072-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-09-18e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A201072-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201072-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201072-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201072-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201072-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201072-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201072-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201072-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201072-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201072-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201072-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201072-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201072-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201072-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201072-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201072-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201072-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201072-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201072-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201072-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201072-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201072-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A201072-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201072-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201072-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201072-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A201072-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201072-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201072-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201072-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201072-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201072-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201072-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201072-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201072-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201072-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201072-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201072-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201072-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201072-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmedetomidine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1018WH7F9IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309710Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1896a96e-25f8-494e-9a96-6463b52fb102Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ec136f1-cd53-4b90-826e-3eaeec54dca0Product name220250401
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
acae4bed-c293-9f7e-61b9-d68b8475ed3aProduct name220230104
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
536fa340-f745-6c4e-1ad7-a3c414722bccProduct name920170706
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-642-01Dexmedetomidine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION21
65219-642-02Dexmedetomidine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION251

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEFresenius Kabi USA, LLC1896a96e-25f8-494e-9a96-6463b52fb1022026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201072
application number: ANDA201072
ndc (product): 65219-642
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEFresenius Kabi USA, LLCc1b8eb58-596b-481d-beb6-ba9d2237abf42025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201072
application number: ANDA201072

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN1896a96e-25f8-494e-9a96-6463b52fb1021
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD1896a96e-25f8-494e-9a96-6463b52fb1021
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY1896a96e-25f8-494e-9a96-6463b52fb1021
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY1896a96e-25f8-494e-9a96-6463b52fb1021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-642-01652190642012 mL in 1 VIAL2 mlHistorical
65219-642-026521906420225 VIAL in 1 TRAY (65219-642-02) / 2 mL in 1 VIAL (65219-642-01) 25 vial2024-12-13NoNoCurrent