FDA.reportPublic FDA data

Midazolam Hydrochloride

Product NDC
0574-0150
11-digit product format
005740150
Labeler code
0574
Product ID
0574-0150_d7b8dd9f-1acd-4d10-afbf-a57a93154a6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Padagis US LLC
Application
ANDA076379
Marketing category
ANDA
Marketing start
2005-05-02
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b84efe2b-3f4e-4b09-90f9-1d24a61ec30eProduct name120190808
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16Product name120181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
31f18c4e-1938-700a-43de-b9e218c36edcProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-0150-04Midazolam Hydrochloride1 in 1 CARTONSYRUP114
0574-0150-04Midazolam Hydrochloride118 mL in 1 BOTTLE, GLASSSYRUP11814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0150-04ML - Milliliter0574-01501f12ebdb-efc8-495e-9650-8a364021bbc712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Midazolam HydrochlorideACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
MidazolamACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
SORBITOLINACTIVE INGREDIENT506T60A25RMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6
WATERINACTIVE INGREDIENT059QF0KO0RMIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-0150MIDAZOLAM HYDROCHLORIDE SYRUP [PADAGIS US LLC]14Current NDC, Legacy NDC, 2 package rows20221211_0be63f63-6a93-4782-8f9c-d13ca5ae44bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422410midazolam 10 MG in 5 mL Oral SolutionPSN1a701d59-3a30-4a4b-a5dd-51f01ba9c5cc100
422410midazolam 2 MG/ML Oral SolutionSCD1a701d59-3a30-4a4b-a5dd-51f01ba9c5cc100
422410midazolam (as midazolam hydrochloride) 10 MG per 5 ML SyrupSY1a701d59-3a30-4a4b-a5dd-51f01ba9c5cc100
422410midazolam (as midazolam hydrochloride) 2 MG/ML SyrupSY1a701d59-3a30-4a4b-a5dd-51f01ba9c5cc100
422410midazolam 10 MG per 5 ML Oral SolutionSY1a701d59-3a30-4a4b-a5dd-51f01ba9c5cc100
422410midazolam 10 MG in 5 mL Oral SolutionPSN0be63f63-6a93-4782-8f9c-d13ca5ae44bd14
422410midazolam 2 MG/ML Oral SolutionSCD0be63f63-6a93-4782-8f9c-d13ca5ae44bd14
422410midazolam (as midazolam hydrochloride) 10 MG per 5 ML SyrupSY0be63f63-6a93-4782-8f9c-d13ca5ae44bd14
422410midazolam (as midazolam hydrochloride) 2 MG/ML SyrupSY0be63f63-6a93-4782-8f9c-d13ca5ae44bd14
422410midazolam 10 MG per 5 ML Oral SolutionSY0be63f63-6a93-4782-8f9c-d13ca5ae44bd14
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0574-0150-04005740150041 BOTTLE, GLASS in 1 CARTON (0574-0150-04) / 118 mL in 1 BOTTLE, GLASS2005-05-020000-00-00NoNoCurrent