FDA.reportPublic FDA data

DEXMEDETOMIDINE

Product NDC
71288-505
11-digit product format
712880505
Labeler code
71288
Product ID
71288-505_74e25a75-2d63-4f39-b6d0-a73392bd1040
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA204843
Marketing category
ANDA
Marketing start
2019-01-18
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DEXMEDETOMIDINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui309710

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
71288-505-02DEXMEDETOMIDINE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26
71288-505-03DEXMEDETOMIDINE25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-505-02ML - Milliliter71288-5056f3c2558-954c-4bf4-9f4c-b72bf01b8d8412021-08-05
71288-505-03ML - Milliliter71288-505126b686c-3cd0-44c7-b78c-d7adb74eb2f112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-505DEXMEDETOMIDINE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20230714_8fa36783-b94d-4084-8c41-40ee64192074.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN8fa36783-b94d-4084-8c41-40ee641920746
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD8fa36783-b94d-4084-8c41-40ee641920746
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY8fa36783-b94d-4084-8c41-40ee641920746
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY8fa36783-b94d-4084-8c41-40ee641920746
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN42dab90e-68c1-bed1-e063-6294a90a4b0c1
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD42dab90e-68c1-bed1-e063-6294a90a4b0c1
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY42dab90e-68c1-bed1-e063-6294a90a4b0c1
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY42dab90e-68c1-bed1-e063-6294a90a4b0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-505-02712880505022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
71288-505-037128805050325 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02) 2019-01-180000-00-00NoNoCurrent