FDA.reportPublic FDA data

Midazolam Hydrochloride

Product NDC
0054-3566
11-digit product format
000543566
Labeler code
0054
Product ID
0054-3566_fba22894-bfd7-4332-9d8b-34fc48389520
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA075873
Marketing category
ANDA
Marketing start
2002-04-30
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
0054-3566-99Midazolam Hydrochloride118 mL in 1 BOTTLE, GLASSSYRUP11810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3566-99ML - Milliliter0054-3566e33662dc-3bf8-48f0-8a9c-584799cfac9c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
SORBITOLINACTIVE INGREDIENT506T60A25RMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
WATERINACTIVE INGREDIENT059QF0KO0RMIDAZOLAM HYDROCHLORIDE SYRUP [ROXANE LABORATORIES, INC]3
Midazolam HydrochlorideACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Midazolam HydrochlorideACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
MidazolamACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
MidazolamACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Edetate disodiumINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Edetate disodiumINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3566MIDAZOLAM HYDROCHLORIDE SYRUP [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 1 package rows20250430_a833c24b-6dca-44d7-a0d6-20012fa1ea77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422410midazolam 10 MG in 5 mL Oral SolutionPSNa833c24b-6dca-44d7-a0d6-20012fa1ea7710
422410midazolam 2 MG/ML Oral SolutionSCDa833c24b-6dca-44d7-a0d6-20012fa1ea7710
422410midazolam (as midazolam hydrochloride) 10 MG per 5 ML SyrupSYa833c24b-6dca-44d7-a0d6-20012fa1ea7710
422410midazolam (as midazolam hydrochloride) 2 MG/ML SyrupSYa833c24b-6dca-44d7-a0d6-20012fa1ea7710
422410midazolam 10 MG per 5 ML Oral SolutionSYa833c24b-6dca-44d7-a0d6-20012fa1ea7710
422410midazolam 10 MG in 5 mL Oral SolutionPSN557ef7bf-9341-47f9-804d-430a24982fa66
422410midazolam 10 MG in 5 mL Oral SolutionPSNe55d49cb-ef77-496f-b74d-05b69ff19df06
422410midazolam 2 MG/ML Oral SolutionSCDe55d49cb-ef77-496f-b74d-05b69ff19df06
422410midazolam 2 MG/ML Oral SolutionSCD557ef7bf-9341-47f9-804d-430a24982fa66
422410midazolam (as midazolam hydrochloride) 10 MG per 5 ML SyrupSY557ef7bf-9341-47f9-804d-430a24982fa66
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 (as midazolam hydrochloride) 2 MG/ML SyrupSY557ef7bf-9341-47f9-804d-430a24982fa66
422410midazolam 10 MG per 5 ML Oral SolutionSYe55d49cb-ef77-496f-b74d-05b69ff19df06
422410midazolam 10 MG per 5 ML Oral SolutionSY557ef7bf-9341-47f9-804d-430a24982fa66
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
0054-3566-9900054356699118 mL in 1 BOTTLE, GLASS (0054-3566-99) 118 ml2002-04-300000-00-00NoNoCurrent