Midazolam Hydrochloride

Product NDC
68258-8973
11-digit product format
682588973
Labeler code
68258
Product ID
68258-8973_8c80bd8d-d5cf-41a5-8391-0a2fc4a76dee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Dispensing Solutions, Inc.
Application
ANDA075857
Marketing category
ANDA
Marketing start
2011-05-02
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
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-8973-12019-11-13C16284748780-197449f38-c30e-f6ea-e053-dbdaa90aa703Midazolam Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-8973-1Midazolam Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21
68258-8973-1Midazolam Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-8973MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 2 package rows20120210_9a0664f8-323e-4960-b1ad-36fd667b3e19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666823midazolam 10 MG in 2 ML InjectionPSN9a0664f8-323e-4960-b1ad-36fd667b3e191
16668232 ML midazolam 5 MG/ML InjectionSCD9a0664f8-323e-4960-b1ad-36fd667b3e191
1666823midazolam 10 MG per 2 ML InjectionSY9a0664f8-323e-4960-b1ad-36fd667b3e191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68258-8973-1682588973012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical