Dexmedetomidine

Product NDC
70860-605
11-digit product format
708600605
Labeler code
70860
Product ID
70860-605_f9e6c4d4-3ea1-4424-be4a-5687c5d5675a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmedetomidine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA209065
Marketing category
ANDA
Marketing start
2018-03-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-605-02ML - Milliliter70860-605baae8c2b-5f00-4958-81ce-144c3188594812018-04-19
70860-605-03ML - Milliliter70860-605aa20bca7-1c3f-4cc9-98c5-e80544e0be9012018-07-03
70860-605-41ML - Milliliter70860-6051d629ec9-5a2b-4f5f-835f-11062acb28f412020-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-605-027086006050210 VIAL in 1 CARTON (70860-605-02) > 2 mL in 1 VIAL (70860-605-41) 10 vial2018-03-010000-00-00NoNoCurrent
70860-605-037086006050325 VIAL in 1 CARTON (70860-605-03) > 2 mL in 1 VIAL (70860-605-41) 25 vial2018-03-010000-00-00NoNoCurrent