Midazolam hydrochloride

Product NDC
23155-601
11-digit product format
231550601
Labeler code
23155
Product ID
23155-601_e20feff9-3aca-4bc1-a5c3-44fff8a9459c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA090850
Marketing category
ANDA
Marketing start
2016-11-07
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
23155-601-31Midazolam hydrochloride5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION57
23155-601-32Midazolam hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION107
23155-601-41Midazolam hydrochloride10 in 1 CARTONINJECTION, SOLUTION107
23155-601-42Midazolam hydrochloride10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-601-31ML - Milliliter23155-60109cf9c73-754e-429c-8f0c-2a0ecfe00b2e12017-03-06
23155-601-32ML - Milliliter23155-6019123cb8a-7df7-4921-baa5-3c1a51267f3712017-03-06
23155-601-41ML - Milliliter23155-60177fcc3a1-e0db-49c2-97e8-9b4552c66a1d12017-03-06
23155-601-42ML - Milliliter23155-601e6149388-45d7-4d65-8296-10db552b8db212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-601MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 4 package rows20230411_843cc25e-45ea-4372-ae34-843f805fa869.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311702midazolam 5 MG/ML Injectable SolutionPSN843cc25e-45ea-4372-ae34-843f805fa8697
311702midazolam 5 MG/ML Injectable SolutionSCD843cc25e-45ea-4372-ae34-843f805fa8697
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSY843cc25e-45ea-4372-ae34-843f805fa8697

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-601-31231550601315 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
23155-601-322315506013210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
23155-601-412315506014110 VIAL, MULTI-DOSE in 1 CARTON (23155-601-41) / 5 mL in 1 VIAL, MULTI-DOSE (23155-601-31) 2016-11-070000-00-00NoNoCurrent
23155-601-422315506014210 VIAL, MULTI-DOSE in 1 CARTON (23155-601-42) / 10 mL in 1 VIAL, MULTI-DOSE (23155-601-32) 2016-11-070000-00-00NoNoCurrent