FDA.reportPublic FDA data

Midazolam

Product NDC
72572-432
11-digit product format
725720432
Labeler code
72572
Product ID
72572-432_1b0844b9-17fb-4f81-b438-6fcbb850a0a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA075243
Marketing category
ANDA
Marketing start
2019-12-10
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
Rxcui1666798, 1666800

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
72572-432-01Midazolam5 mL in 1 VIALINJECTION54
72572-432-10Midazolam10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-432-01ML - Milliliter72572-4323c063680-7c25-4e6e-a266-1bdbda0a7f8612020-01-03
72572-432-10ML - Milliliter72572-432ecdef888-3dd2-47fc-b608-1d1654d8e4f712020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-432MIDAZOLAM INJECTION [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20241228_f0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666798midazolam 2 MG in 2 ML InjectionPSNf0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b4
1666800midazolam 5 MG in 5 ML InjectionPSNf0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b4
16667982 ML midazolam 1 MG/ML InjectionSCDf0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b4
16668005 ML midazolam 1 MG/ML InjectionSCDf0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b4
1666798midazolam 2 MG per 2 ML InjectionSYf0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b4
1666800midazolam 5 MG per 5 ML InjectionSYf0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-432-01725720432015 mL in 1 VIAL5 mlHistorical
72572-432-107257204321010 VIAL in 1 CARTON (72572-432-10) / 5 mL in 1 VIAL (72572-432-01) 10 vial2019-12-100000-00-00NoNoCurrent