Midazolam

Product NDC
0404-9915
11-digit product format
004049915
Labeler code
0404
Product ID
0404-9915_69f7e7ff-2ac4-4df5-8c26-6e5eb13783f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA075293
Marketing category
ANDA
Marketing start
2022-01-13
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
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
0404-9915-05Midazolam5 mL in 1 VIALINJECTION, SOLUTION56
0404-9915-05Midazolam1 in 1 BAGINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9915MIDAZOLAM INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20240406_90f7b7f6-d0fd-40af-bbfa-70b152e3e27c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311702midazolam 5 MG/ML Injectable SolutionPSN90f7b7f6-d0fd-40af-bbfa-70b152e3e27c6
311702midazolam 5 MG/ML Injectable SolutionSCD90f7b7f6-d0fd-40af-bbfa-70b152e3e27c6
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSY90f7b7f6-d0fd-40af-bbfa-70b152e3e27c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9915-05004049915051 VIAL in 1 BAG (0404-9915-05) / 5 mL in 1 VIAL1 vial2022-01-130000-00-00NoNoCurrent