FDA.reportPublic FDA data

Midazolam in Sodium Chloride

Product NDC
44567-610
11-digit product format
445670610
Labeler code
44567
Product ID
44567-610_6cea9d5b-d0a6-4f93-b45e-2d615f6c4337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC.
Application
NDA211844
Marketing category
NDA
Marketing start
2020-12-31
Substance
MIDAZOLAM
Active strength
1 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Midazolam in Sodium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR60L0SM5BC
Rxcui2541170, 2541171

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
44567-610-01Midazolam in Sodium Chloride50 mL in 1 BAGINJECTION, SOLUTION5015
44567-610-10Midazolam in Sodium Chloride10 in 1 CARTONINJECTION, SOLUTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-610-01ML - Milliliter44567-610c1eeccb6-5999-4c70-8ddb-c3301bd3562812021-09-07
44567-610-10ML - Milliliter44567-610292024a2-13b4-4792-af64-3cbbeb864e4512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-610MIDAZOLAM IN SODIUM CHLORIDE (MIDAZOLAM) INJECTION, SOLUTION [WG CRITICAL CARE, LLC.]12Current NDC, Legacy NDC, 2 package rows20250108_f051776f-94c5-4e34-80ed-f45b9c36881e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2541171midazolam 100 MG in 100 mL InjectionPSNf051776f-94c5-4e34-80ed-f45b9c36881e15
2541170midazolam 50 MG in 50 mL InjectionPSNf051776f-94c5-4e34-80ed-f45b9c36881e15
2541171100 ML midazolam 1 MG/ML InjectionSCDf051776f-94c5-4e34-80ed-f45b9c36881e15
254117050 ML midazolam 1 MG/ML InjectionSCDf051776f-94c5-4e34-80ed-f45b9c36881e15
2541171midazolam 100 MG per 100 ML InjectionSYf051776f-94c5-4e34-80ed-f45b9c36881e15
2541170midazolam 50 MG per 50 ML InjectionSYf051776f-94c5-4e34-80ed-f45b9c36881e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-610-014456706100150 mL in 1 BAG50 mlHistorical
44567-610-104456706101010 BAG in 1 CARTON (44567-610-10) / 50 mL in 1 BAG (44567-610-01) 10 bag2021-04-190000-00-00NoNoCurrent