FDA.reportPublic FDA data

Dexmedetomidine

Product NDC
71872-7323
11-digit product format
718727323
Labeler code
71872
Product ID
71872-7323_12ef0602-bf08-6ddd-e063-6294a90a23c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA202126
Marketing category
ANDA
Marketing start
2021-01-19
Substance
DEXMEDETOMIDINE HYDROCHLORIDE
Active strength
200 ug/2mL
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 HYDROCHLORIDE200 ug/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui309710

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ec136f1-cd53-4b90-826e-3eaeec54dca0Product name220250401
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
acae4bed-c293-9f7e-61b9-d68b8475ed3aProduct name220230104
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
536fa340-f745-6c4e-1ad7-a3c414722bccProduct name920170706
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7323-1Dexmedetomidine1 in 1 BAGINJECTION, SOLUTION11
71872-7323-1Dexmedetomidine2 mL in 1 VIAL, GLASSINJECTION, SOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7323DEXMEDETOMIDINE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Current NDC, 2 package rows20240307_12ef0602-bf07-6ddd-e063-6294a90a23c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN12ef0602-bf07-6ddd-e063-6294a90a23c31
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD12ef0602-bf07-6ddd-e063-6294a90a23c31
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY12ef0602-bf07-6ddd-e063-6294a90a23c31
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY12ef0602-bf07-6ddd-e063-6294a90a23c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7323-1718727323011 VIAL, GLASS in 1 BAG (71872-7323-1) / 2 mL in 1 VIAL, GLASS2024-01-22NoNoCurrent