Midazolam Hydrochloride

Product NDC
50090-5472
11-digit product format
500905472
Labeler code
50090
Product ID
50090-5472_cb0416fe-b4c5-4935-b6b7-d3cf1d276f18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDAZOLAM HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA075293
Marketing category
ANDA
Marketing start
2006-02-02
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Midazolam Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW7TTW573JJ
Rxcui311700

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5472-02023-02-06C16284748780-1f386c649-f8fb-0266-e053-dadaa90a7c1aMidazolam Injection, USP
50090-5472-02023-01-30C16284748780-1f386c649-f8fb-0266-e053-dadaa90a7c1aMidazolam Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5472-0Midazolam Hydrochloride10 in 1 BOXINJECTION, SOLUTION106
50090-5472-0Midazolam Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5472MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20241023_b7effb82-e180-46f0-b2e8-a0d8ebc32a2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311700midazolam 1 MG/ML Injectable SolutionPSNb7effb82-e180-46f0-b2e8-a0d8ebc32a2a6
311700midazolam 1 MG/ML Injectable SolutionSCDb7effb82-e180-46f0-b2e8-a0d8ebc32a2a6
311700midazolam (as midazolam hydrochloride) 1 MG/ML Injectable SolutionSYb7effb82-e180-46f0-b2e8-a0d8ebc32a2a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5472-05009054720010 VIAL in 1 BOX (50090-5472-0) / 10 mL in 1 VIAL10 vial2021-02-260000-00-00NoNoCurrent