Midazolam

Product NDC
0404-9913
11-digit product format
004049913
Labeler code
0404
Product ID
0404-9913_09538099-2828-4215-9a17-3b9a100134cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA075243
Marketing category
ANDA
Marketing start
2022-01-13
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
1 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 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9913-05Midazolam1 in 1 BAGINJECTION15
0404-9913-05Midazolam5 mL in 1 VIALINJECTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9913MIDAZOLAM INJECTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20241018_3c2fd6ee-4ede-4ee4-8c05-34c93598f381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311700midazolam 1 MG/ML Injectable SolutionPSN3c2fd6ee-4ede-4ee4-8c05-34c93598f3815
311700midazolam 1 MG/ML Injectable SolutionSCD3c2fd6ee-4ede-4ee4-8c05-34c93598f3815
311700midazolam (as midazolam hydrochloride) 1 MG/ML Injectable SolutionSY3c2fd6ee-4ede-4ee4-8c05-34c93598f3815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9913-05004049913051 VIAL in 1 BAG (0404-9913-05) / 5 mL in 1 VIAL1 vial2022-01-130000-00-00NoNoCurrent