Midazolam Hydrochloride

Product NDC
17856-3566
11-digit product format
178563566
Labeler code
17856
Product ID
17856-3566_df782df5-b572-4a09-9015-29a41bda566c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA075873
Marketing category
ANDA
Marketing start
2002-04-30
Marketing end
0000-00-00
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3566-1Midazolam Hydrochloride2 mL in 1 CUPSYRUP26
17856-3566-3Midazolam Hydrochloride5 mL in 1 CUPSYRUP56
17856-3566-5Midazolam Hydrochloride5 mL in 1 SYRINGESYRUP56
17856-3566-5Midazolam Hydrochloride48 in 1 BOX, UNIT-DOSESYRUP486

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-3566-3ML - Milliliter17856-35664f640962-2793-4815-810e-6eae0c36f0fc12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3566MIDAZOLAM HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.]6Legacy NDC, 4 package rows20240522_e55d49cb-ef77-496f-b74d-05b69ff19df0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422410midazolam 10 MG in 5 mL Oral SolutionPSNe55d49cb-ef77-496f-b74d-05b69ff19df06
422410midazolam 2 MG/ML Oral SolutionSCDe55d49cb-ef77-496f-b74d-05b69ff19df06
422410midazolam (as midazolam hydrochloride) 10 MG per 5 ML SyrupSYe55d49cb-ef77-496f-b74d-05b69ff19df06
422410midazolam (as midazolam hydrochloride) 2 MG/ML SyrupSYe55d49cb-ef77-496f-b74d-05b69ff19df06
422410midazolam 10 MG per 5 ML Oral SolutionSYe55d49cb-ef77-496f-b74d-05b69ff19df06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-3566-1178563566012 mL in 1 CUP (17856-3566-1) 2 ml2021-09-160000-00-00NoNoCurrent
17856-3566-3178563566035 mL in 1 CUP (17856-3566-3) 5 ml2021-09-160000-00-00NoNoCurrent
17856-3566-51785635660548 SYRINGE in 1 BOX, UNIT-DOSE (17856-3566-5) > 5 mL in 1 SYRINGE48 syringe2021-09-160000-00-00NoNoCurrent