FDA.reportPublic FDA data

Midazolam Hydrochloride

Product NDC
60687-576
11-digit product format
606870576
Labeler code
60687
Product ID
60687-576_34f38926-e4e4-8bae-e063-6394a90a60ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075873
Marketing category
ANDA
Marketing start
2021-06-15
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
2 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW7TTW573JJ
Rxcui422410

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
60687-576-03Midazolam Hydrochloride2.5 mL in 1 CUP, UNIT-DOSESYRUP2.54
60687-576-04Midazolam Hydrochloride10 in 1 TRAYSYRUP104
60687-576-10Midazolam Hydrochloride3 in 1 CASESYRUP34
60687-576-40Midazolam Hydrochloride5 mL in 1 CUP, UNIT-DOSESYRUP54
60687-576-46Midazolam Hydrochloride10 in 1 TRAYSYRUP104
60687-576-86Midazolam Hydrochloride3 in 1 CASESYRUP34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-576MIDAZOLAM HYDROCHLORIDE SYRUP [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 6 package rows20250514_fc93242b-0abf-466a-8413-8a365620ee75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422410midazolam 10 MG in 5 mL Oral SolutionPSNfc93242b-0abf-466a-8413-8a365620ee754
422410midazolam 2 MG/ML Oral SolutionSCDfc93242b-0abf-466a-8413-8a365620ee754
422410midazolam (as midazolam hydrochloride) 10 MG per 5 ML SyrupSYfc93242b-0abf-466a-8413-8a365620ee754
422410midazolam (as midazolam hydrochloride) 2 MG/ML SyrupSYfc93242b-0abf-466a-8413-8a365620ee754
422410midazolam 10 MG per 5 ML Oral SolutionSYfc93242b-0abf-466a-8413-8a365620ee754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-576-03606870576032.5 mL in 1 CUP, UNIT-DOSE2.5 mlHistorical
60687-576-046068705760410 in 1 TRAYHistorical
60687-576-10606870576103 TRAY in 1 CASE (60687-576-10) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-04) / 2.5 mL in 1 CUP, UNIT-DOSE (60687-576-03) 3 tray2021-06-150000-00-00NoNoCurrent
60687-576-40606870576405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-576-466068705764610 in 1 TRAYHistorical
60687-576-86606870576863 TRAY in 1 CASE (60687-576-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-576-40) 3 tray2021-06-150000-00-00NoNoCurrent