Midazolam Hydrochloride

Product NDC
86211-111
11-digit product format
862110111
Labeler code
86211
Product ID
86211-111_ad8a2323-085c-41eb-bbbd-718c9ea50f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Jvet Pharmaceuticals LLC
Application
ANDA090850
Marketing category
ANDA
Marketing start
2025-10-21
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Midazolam Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW7TTW573JJ
Rxcui311702

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d526338-43ba-4cef-8730-5a757122f8ceProduct name120260218
8118475d-d61b-4326-b353-56e9cf8c8d9fProduct name320260218
f69f3735-bf62-03e6-cc7a-5af4af89ec8aProduct name520250516
4cc03496-da49-494d-b71d-757fe6737fa2Product name120230717
06641162-4d53-492d-8ff2-5951a469060fProduct name120230420
46ca420c-e4d5-4e6c-9b2f-cea269a262e8Product name120230320
b84efe2b-3f4e-4b09-90f9-1d24a61ec30eProduct name120190808
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16Product name120181220
31f18c4e-1938-700a-43de-b9e218c36edcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86211-111-10Midazolam Hydrochloride10 in 1 CARTONINJECTION, SOLUTION102
86211-111-10Midazolam Hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311702midazolam 5 MG/ML Injectable SolutionPSNa84ddd02-1f5f-4311-9dae-2a5cb4064bf32
311702midazolam 5 MG/ML Injectable SolutionSCDa84ddd02-1f5f-4311-9dae-2a5cb4064bf32
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSYa84ddd02-1f5f-4311-9dae-2a5cb4064bf32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
86211-111-108621101111010 VIAL, MULTI-DOSE in 1 CARTON (86211-111-10) / 10 mL in 1 VIAL, MULTI-DOSE2025-10-21NoNoCurrent