Dexmedetomidine

Product NDC
68083-527
11-digit product format
680830527
Labeler code
68083
Product ID
68083-527_daec1549-17b5-483b-8efe-55b936be5174
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA202126
Marketing category
ANDA
Marketing start
2021-06-28
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 1.

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
A202126-001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202126-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-203f01610625f2…
2019-09-15 20:21 UTC2019-09A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202126-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2015-08-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202126-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202126-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202126-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202126-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202126-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202126-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202126-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202126-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202126-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202126-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202126-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202126-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202126-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202126-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202126-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202126-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202126-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202126-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202126-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202126-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202126-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A202126-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202126-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202126-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202126-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A202126-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202126-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202126-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202126-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202126-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202126-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202126-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202126-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202126-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202126-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202126-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202126-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202126-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202126-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202126-001AP1cb3db0bc1861…

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
714cc0d2-8a4c-40c0-8ef0-dcfde4c46989Available 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
68083-527-25Dexmedetomidine25 in 1 CARTONINJECTION, SOLUTION254
68083-527-25Dexmedetomidine2 mL in 1 VIALINJECTION, SOLUTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-527DEXMEDETOMIDINE INJECTION, SOLUTION [GLAND PHARMA LIMITED]1Current NDC, 2 package rows20230625_714cc0d2-8a4c-40c0-8ef0-dcfde4c46989.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexmedetomidineDEXMEDETOMIDINEPiramal Critical Care Incc116d83f-35da-19ca-e053-2a95a90a017d2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202126
application number: ANDA202126
DexmedetomidineDEXMEDETOMIDINEPiramal Critical Care Incb93a71ed-0f9e-1ff9-e053-2995a90a789d2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202126
application number: ANDA202126
DexmedetomidineDEXMEDETOMIDINEGland Pharma Limited714cc0d2-8a4c-40c0-8ef0-dcfde4c469892026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202126
application number: ANDA202126
ndc (product): 68083-527
DexmedetomidineDEXMEDETOMIDINEProPharma Distribution42cbeadf-fea3-d2ae-e063-6394a90ad5492025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202126
application number: ANDA202126
DexmedetomidineDEXMEDETOMIDINEMedical Purchasing Solutions, LLC12ef0602-bf07-6ddd-e063-6294a90a23c32024-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202126
application number: ANDA202126
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6937235f-ea25-4950-e053-2991aa0a9b742023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202126
application number: ANDA202126
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESun Pharmaceuticals Industries, Inc.4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa2018-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202126
application number: ANDA202126

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN714cc0d2-8a4c-40c0-8ef0-dcfde4c469894
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD714cc0d2-8a4c-40c0-8ef0-dcfde4c469894
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY714cc0d2-8a4c-40c0-8ef0-dcfde4c469894
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY714cc0d2-8a4c-40c0-8ef0-dcfde4c469894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-527-256808305272525 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL25 vial2021-06-28NoNoCurrent