Midazolam Hydrochloride

Product NDC
17856-0146
11-digit product format
178560146
Labeler code
17856
Product ID
17856-0146_0adc03c2-5426-4073-a6c5-e349f742ee25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA076379
Marketing category
ANDA
Marketing start
2018-05-18
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
17856-0146-1Midazolam Hydrochloride5 mL in 1 CUP, UNIT-DOSESYRUP53
17856-0146-2Midazolam Hydrochloride5 mL in 1 SYRINGESYRUP53
17856-0146-2Midazolam Hydrochloride48 in 1 BOX, UNIT-DOSESYRUP483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0146MIDAZOLAM HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 3 package rows20210220_71a26b37-755a-4b00-8d77-fabbb92d6ff5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422410midazolam 10 MG in 5 mL Oral SolutionPSN71a26b37-755a-4b00-8d77-fabbb92d6ff53
422410midazolam 2 MG/ML Oral SolutionSCD71a26b37-755a-4b00-8d77-fabbb92d6ff53
422410midazolam (as midazolam hydrochloride) 10 MG per 5 ML SyrupSY71a26b37-755a-4b00-8d77-fabbb92d6ff53
422410midazolam (as midazolam hydrochloride) 2 MG/ML SyrupSY71a26b37-755a-4b00-8d77-fabbb92d6ff53
422410midazolam 10 MG per 5 ML Oral SolutionSY71a26b37-755a-4b00-8d77-fabbb92d6ff53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0146-1178560146015 mL in 1 CUP, UNIT-DOSE (17856-0146-1) 5 ml2021-02-190000-00-00NoNoCurrent
17856-0146-21785601460248 SYRINGE in 1 BOX, UNIT-DOSE (17856-0146-2) > 5 mL in 1 SYRINGE48 syringe2021-02-190000-00-00NoNoCurrent