Dexmedetomidine

Product NDC
67457-251
11-digit product format
674570251
Labeler code
67457
Product ID
67457-251_afa561b9-9d6c-47b3-87e6-8d049597a0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA202881
Marketing category
ANDA
Marketing start
2014-08-18
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
A202881-001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202881-001AP

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 06:07:402026-07A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202881-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2014-08-18e64feba35796…

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 06:07:402026-07A202881-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202881-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202881-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202881-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202881-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202881-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202881-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202881-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202881-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202881-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202881-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202881-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202881-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202881-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202881-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202881-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202881-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202881-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202881-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202881-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202881-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202881-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A202881-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202881-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202881-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202881-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A202881-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202881-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202881-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202881-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202881-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202881-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202881-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202881-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202881-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202881-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202881-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202881-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202881-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202881-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmedetomidine
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
ebdfe2e8-30ca-4f18-935a-41bcbbce4937Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ec136f1-cd53-4b90-826e-3eaeec54dca0Product name220250401
acae4bed-c293-9f7e-61b9-d68b8475ed3aProduct name220230104
536fa340-f745-6c4e-1ad7-a3c414722bccProduct name920170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-251-00Dexmedetomidine2 mL in 1 VIAL, GLASSINJECTION, SOLUTION, CONCENTRATE221
67457-251-02Dexmedetomidine25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE2521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-251-00ML - Milliliter67457-25129ed2165-551f-4979-bd68-ef6f9aa04dd012014-09-03
67457-251-02ML - Milliliter67457-25116ddaf7e-3658-4af8-9999-ba48c57f965f12014-09-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-251DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]20Current NDC, Legacy NDC, 2 package rows20250410_ebdfe2e8-30ca-4f18-935a-41bcbbce4937.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexmedetomidineDEXMEDETOMIDINEMylan Institutional LLCebdfe2e8-30ca-4f18-935a-41bcbbce49372026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202881
application number: ANDA202881
ndc (product): 67457-251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNebdfe2e8-30ca-4f18-935a-41bcbbce493721
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDebdfe2e8-30ca-4f18-935a-41bcbbce493721
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYebdfe2e8-30ca-4f18-935a-41bcbbce493721
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYebdfe2e8-30ca-4f18-935a-41bcbbce493721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-251-00674570251002 mL in 1 VIAL, GLASS2 mlHistorical
67457-251-026745702510225 VIAL, GLASS in 1 CARTON (67457-251-02) / 2 mL in 1 VIAL, GLASS (67457-251-00) 2014-08-180000-00-00NoNoCurrent