Midazolam

Product NDC
70860-601
11-digit product format
708600601
Labeler code
70860
Product ID
70860-601_6e1139fb-a7c4-43dc-a85e-8556b3397f59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midazolam hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA090850
Marketing category
ANDA
Marketing start
2016-12-14
Marketing end
0000-00-00
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
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
70860-601-05ML - Milliliter70860-601720ac357-ba07-40d1-b568-7ce3f33594fb12017-03-06
70860-601-10ML - Milliliter70860-6019a7534aa-3f0d-46f8-9b46-ac694ffb50a912017-03-06
70860-601-41ML - Milliliter70860-60172761760-9c37-4021-bc0b-fcb545b300d812019-04-11
70860-601-42ML - Milliliter70860-601281c54e5-19ee-4e6f-ae9b-7552333bb1ba12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-601MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]9Legacy NDC20240306_d71724e5-0613-4e01-a589-433eb29a9bbb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70860-601-057086006010510 VIAL, MULTI-DOSE in 1 CARTON (70860-601-05) > 5 mL in 1 VIAL, MULTI-DOSE (70860-601-41) 2016-12-140000-00-00NoNoCurrent
70860-601-107086006011010 VIAL, MULTI-DOSE in 1 CARTON (70860-601-10) > 10 mL in 1 VIAL, MULTI-DOSE (70860-601-42) 2016-12-140000-00-00NoNoCurrent