MIDAZOLAM IN 0.8% SODIUM CHLORIDE

Product NDC
0264-8005
11-digit product format
002648005
Labeler code
0264
Product ID
0264-8005_1287da80-6b0a-4ba3-b698-d1dc0e78c294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDAZOLAM IN 0.8% SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
ANDA218454
Marketing category
ANDA
Marketing start
2025-10-15
Substance
MIDAZOLAM
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 IN 0.8% SODIUM CHLORIDE
Listing expiration
2026-12-31

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
0264-8005-31MIDAZOLAM IN 0.8% SODIUM CHLORIDE50 mL in 1 CONTAINERINJECTION, SOLUTION503
0264-8005-31MIDAZOLAM IN 0.8% SODIUM CHLORIDE40 in 1 CASEINJECTION, SOLUTION403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-8005-31ML - Milliliter0264-800595ea5520-1d0f-4a35-aa8e-b93ac1a60d1612025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2541171midazolam 100 MG in 100 mL InjectionPSNadfe8ece-496d-4118-9990-a1d44d0ac7d93
2541170midazolam 50 MG in 50 mL InjectionPSNadfe8ece-496d-4118-9990-a1d44d0ac7d93
2541171100 ML midazolam 1 MG/ML InjectionSCDadfe8ece-496d-4118-9990-a1d44d0ac7d93
254117050 ML midazolam 1 MG/ML InjectionSCDadfe8ece-496d-4118-9990-a1d44d0ac7d93
2541171midazolam 100 MG per 100 ML InjectionSYadfe8ece-496d-4118-9990-a1d44d0ac7d93
2541170midazolam 50 MG per 50 ML InjectionSYadfe8ece-496d-4118-9990-a1d44d0ac7d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0264-8005-310026480053140 CONTAINER in 1 CASE (0264-8005-31) / 50 mL in 1 CONTAINER40 container2025-10-15NoNoHistorical