Dexmedetomidine

Product NDC
83634-600
11-digit product format
836340600
Labeler code
83634
Product ID
83634-600_3e30e931-4d42-465c-9e4b-cd3137ba5fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Avenacy Inc.
Application
ANDA209065
Marketing category
ANDA
Marketing start
2024-03-15
Marketing end
2027-04-01
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
2026-12-31
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 · 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…

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmedetomidine

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
eee6145b-d83f-4596-92d3-733934d8a3a4Available 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
83634-600-02Dexmedetomidine25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE251
83634-600-41Dexmedetomidine2 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83634-600-02ML - Milliliter83634-600fd0bfd35-7f76-4a5e-982a-209739bc524212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-600DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE [AVENACY INC.]1Current NDC, 2 package rows20240316_eee6145b-d83f-4596-92d3-733934d8a3a4.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
ndc (product): 83634-600
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSNeee6145b-d83f-4596-92d3-733934d8a3a41
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCDeee6145b-d83f-4596-92d3-733934d8a3a41
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSYeee6145b-d83f-4596-92d3-733934d8a3a41
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSYeee6145b-d83f-4596-92d3-733934d8a3a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83634-600-028363406000225 VIAL in 1 CARTON (83634-600-02) / 2 mL in 1 VIAL (83634-600-41) 25 vial2024-03-152027-04-01NoNoHistorical
83634-600-41836340600412 mL in 1 VIAL2 mlHistorical