Midazolam

Product NDC
50090-3435
11-digit product format
500903435
Labeler code
50090
Product ID
50090-3435_7d153af7-feb4-44b9-85cd-091327bfe8c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midazolam hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA090850
Marketing category
ANDA
Marketing start
2017-08-11
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

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3435-12023-01-30C16284748780-1f386c649-a522-0266-e053-dadaa90a7c1aMidazolam Injection, USP CIV (For Intravenous or Intramuscular Use Only)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3435-1Midazolam10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
50090-3435-1Midazolam10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3435-1ML - Milliliter50090-3435cc945a8f-9dbc-44c8-acc3-6de0731bc8e912019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3435MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20190205_3060c8c6-7de2-45af-84fc-2ea37d0de071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311702midazolam 5 MG/ML Injectable SolutionPSN3060c8c6-7de2-45af-84fc-2ea37d0de0712
311702midazolam 5 MG/ML Injectable SolutionSCD3060c8c6-7de2-45af-84fc-2ea37d0de0712
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSY3060c8c6-7de2-45af-84fc-2ea37d0de0712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3435-15009034350110 VIAL, MULTI-DOSE in 1 CARTON (50090-3435-1) > 10 mL in 1 VIAL, MULTI-DOSE2018-04-200000-00-00NoNoCurrent