FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
36000-262
Requested package NDC
36000-262-10
11-digit product format
360000262
Labeler code
36000
Product ID
36000-262_f0a53e8e-e8cc-4b2d-b8f0-2d99b01f6cc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine hydrochloride
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA208103
Marketing category
ANDA
Marketing start
2026-04-16
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
A208103-001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2026-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208103-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208103-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)INJECTABLE / INJECTIONAP2026-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208103-001AP1a50c72e98297…

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
7d057255-22a1-4b69-ad7c-7337fac8e993Available 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
36000-262-01Dexmedetomidine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE29
36000-262-05Dexmedetomidine Hydrochloride5 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE59
36000-262-10Dexmedetomidine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE109
36000-262-25Dexmedetomidine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE259

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
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare Corporation7d057255-22a1-4b69-ad7c-7337fac8e9932026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208103
application number: ANDA208103
ndc (package): 36000-262-10
ndc (product): 36000-262
ndc11 (package): 36000026210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN7d057255-22a1-4b69-ad7c-7337fac8e9939
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD7d057255-22a1-4b69-ad7c-7337fac8e9939
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY7d057255-22a1-4b69-ad7c-7337fac8e9939
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY7d057255-22a1-4b69-ad7c-7337fac8e9939

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
36000-262-103600002621010 VIAL, SINGLE-DOSE in 1 CARTON (36000-262-10) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01) 2026-04-16NoNoCurrent