FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride

Product NDC
25021-615
11-digit product format
250210615
Labeler code
25021
Product ID
25021-615_18a919fe-92bd-4e01-a966-7334eb31b844
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA217308
Marketing category
ANDA
Marketing start
2024-02-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui1718906, 1718909

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
25021-615-50Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride50 mL in 1 BOTTLEINJECTION, SOLUTION502
25021-615-50Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride10 in 1 CARTONINJECTION, SOLUTION102
25021-615-51Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride10 in 1 CARTONINJECTION, SOLUTION102
25021-615-51Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride100 mL in 1 BOTTLEINJECTION, SOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-615-50ML - Milliliter25021-6154e619a1d-a46a-4d05-9c01-652b26b1505b12024-05-16
25021-615-51ML - Milliliter25021-615c7d5a64f-3922-4db3-902c-5591fb6f760512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-615DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2Current NDC, 4 package rows20240417_a99335d0-1e87-4180-bde3-cbb12bf91a52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNa99335d0-1e87-4180-bde3-cbb12bf91a522
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNa99335d0-1e87-4180-bde3-cbb12bf91a522
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDa99335d0-1e87-4180-bde3-cbb12bf91a522
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDa99335d0-1e87-4180-bde3-cbb12bf91a522
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYa99335d0-1e87-4180-bde3-cbb12bf91a522
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYa99335d0-1e87-4180-bde3-cbb12bf91a522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-615-502502106155010 BOTTLE in 1 CARTON (25021-615-50) / 50 mL in 1 BOTTLE10 bottle2024-02-15NoNoCurrent
25021-615-512502106155110 BOTTLE in 1 CARTON (25021-615-51) / 100 mL in 1 BOTTLE10 bottle2024-02-15NoNoCurrent