FDA.reportPublic FDA data

Midazolam hydrochloride

Product NDC
23155-600
11-digit product format
231550600
Labeler code
23155
Product ID
23155-600_0703352c-df9e-40fb-be00-0742a2511a7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA090696
Marketing category
ANDA
Marketing start
2016-11-08
Substance
MIDAZOLAM HYDROCHLORIDE
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 hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW7TTW573JJ
Rxcui1666798

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
23155-600-31Midazolam hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION213
23155-600-41Midazolam hydrochloride25 in 1 CARTONINJECTION, SOLUTION2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-600-31ML - Milliliter23155-6005d39f1ef-06f4-41ad-9d54-e2bd4bf1a8c712017-03-06
23155-600-41ML - Milliliter23155-600c5f6706b-0c8c-48d6-834b-52fc379185c912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-600MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20241220_8b690f5c-2923-4c34-a8f7-11af5f546b62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666798midazolam 2 MG in 2 ML InjectionPSN8b690f5c-2923-4c34-a8f7-11af5f546b6213
16667982 ML midazolam 1 MG/ML InjectionSCD8b690f5c-2923-4c34-a8f7-11af5f546b6213
1666798midazolam 2 MG per 2 ML InjectionSY8b690f5c-2923-4c34-a8f7-11af5f546b6213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-600-31231550600312 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
23155-600-412315506004125 VIAL, SINGLE-DOSE in 1 CARTON (23155-600-41) / 2 mL in 1 VIAL, SINGLE-DOSE (23155-600-31) 2016-11-080000-00-00NoNoCurrent