FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
70121-1388
11-digit product format
701211388
Labeler code
70121
Product ID
70121-1388_795f643f-855c-4ba4-9bad-a96334c1a2fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207551
Marketing category
ANDA
Marketing start
2020-05-20
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
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
70121-1388-1Dexmedetomidine Hydrochloride50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5018
70121-1388-8Dexmedetomidine Hydrochloride20 in 1 CARTONINJECTION, SOLUTION2018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1388-1ML - Milliliter70121-1388235c0f4f-6ea9-40a9-8a7e-b9f32c6f758812020-07-13
70121-1388-8ML - Milliliter70121-13884dfd0a6c-af86-46b4-90fa-e34045bd34fa12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1388DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 2 package rows20240707_eb1ba463-ab42-4f49-9ebe-3ad5af108326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSNeb1ba463-ab42-4f49-9ebe-3ad5af10832618
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSNeb1ba463-ab42-4f49-9ebe-3ad5af10832618
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCDeb1ba463-ab42-4f49-9ebe-3ad5af10832618
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCDeb1ba463-ab42-4f49-9ebe-3ad5af10832618
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSYeb1ba463-ab42-4f49-9ebe-3ad5af10832618
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSYeb1ba463-ab42-4f49-9ebe-3ad5af10832618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1388-17012113880150 mL in 1 BOTTLE, GLASS50 mlHistorical
70121-1388-87012113880820 BOTTLE, GLASS in 1 CARTON (70121-1388-8) / 50 mL in 1 BOTTLE, GLASS (70121-1388-1) 2020-05-200000-00-00NoNoCurrent