Dexmedetomidine Hydrochloride

Product NDC
68083-238
11-digit product format
680830238
Labeler code
68083
Product ID
68083-238_29930c5a-6908-4686-aa11-1560abca3c7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA209307
Marketing category
ANDA
Marketing start
2020-06-03
Substance
DEXMEDETOMIDINE HYDROCHLORIDE
Active strength
4 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209307-001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03
A209307-002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209307-001AP
A209307-002AP

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 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-034b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209307-001DEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A209307-002DEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE / INJECTIONAP2020-06-03782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209307-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A209307-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209307-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209307-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209307-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209307-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209307-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209307-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209307-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209307-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209307-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209307-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209307-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209307-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209307-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209307-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209307-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209307-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209307-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209307-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209307-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209307-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209307-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209307-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209307-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209307-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209307-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209307-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209307-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209307-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209307-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209307-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209307-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209307-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209307-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209307-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209307-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209307-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209307-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209307-002AP1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1718906Internal RxNorm lookup
1718909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f307de7e-a9ab-4734-abb7-66b4e112bc51Available 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
68083-238-20Dexmedetomidine Hydrochloride50 mL in 1 VIALINJECTION5013
68083-238-20Dexmedetomidine Hydrochloride20 in 1 CARTONINJECTION2013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-238DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED]11Current NDC, Legacy NDC, 2 package rows20241222_f307de7e-a9ab-4734-abb7-66b4e112bc51.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEPiramal Critical Care Incc958aeb4-69ce-c3e2-e053-2a95a90a6d8d2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209307
application number: ANDA209307
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEGland Pharma Limitedf307de7e-a9ab-4734-abb7-66b4e112bc512026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209307
application number: ANDA209307
ndc (product): 68083-238
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESagent Pharmaceuticals65885aef-faaf-4dec-a180-9a657f738bbc2025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209307
application number: ANDA209307
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEDr.Reddy's Laboratories Incd174c19d-56f1-4ef4-087c-23c26db8e40b2022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209307
application number: ANDA209307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNf307de7e-a9ab-4734-abb7-66b4e112bc5113
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNf307de7e-a9ab-4734-abb7-66b4e112bc5113
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDf307de7e-a9ab-4734-abb7-66b4e112bc5113
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDf307de7e-a9ab-4734-abb7-66b4e112bc5113
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYf307de7e-a9ab-4734-abb7-66b4e112bc5113
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYf307de7e-a9ab-4734-abb7-66b4e112bc5113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-238-206808302382020 VIAL in 1 CARTON (68083-238-20) / 50 mL in 1 VIAL20 vial2020-06-030000-00-00NoNoCurrent