FDA.reportPublic FDA data

Midazolam

Product NDC
63323-411
11-digit product format
633230411
Labeler code
63323
Product ID
63323-411_9814447b-a93e-42ad-b57e-5db0a5b7f552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDAZOLAM HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075154
Marketing category
ANDA
Marketing start
2000-07-14
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
1 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW7TTW573JJ
Rxcui311700, 311702

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
63323-411-10Midazolam10 in 1 TRAYINJECTION, SOLUTION107
63323-411-12Midazolam25 in 1 TRAYINJECTION, SOLUTION257
63323-411-13Midazolam10 mL in 1 VIALINJECTION, SOLUTION107
63323-411-15Midazolam2 mL in 1 VIALINJECTION, SOLUTION27
63323-411-18Midazolam5 mL in 1 VIALINJECTION, SOLUTION57
63323-411-22Midazolam2 mL in 1 VIALINJECTION, SOLUTION27
63323-411-25Midazolam25 in 1 TRAYINJECTION, SOLUTION257
63323-411-27Midazolam25 in 1 TRAYINJECTION, SOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-411-10ML - Milliliter63323-4112df2af60-bca0-402b-a097-70b53f99381912013-02-13
63323-411-12ML - Milliliter63323-4112cff44d4-338d-4a76-b352-4d26975a85ea12013-02-13
63323-411-13ML - Milliliter63323-4112b1c2aa9-4b0b-4553-bfb9-21c68a9b0cf312019-08-06
63323-411-15ML - Milliliter63323-411d935f282-571e-4855-aa9f-065c7b5cd79812019-01-24
63323-411-18ML - Milliliter63323-4119e75e2b8-4228-4ad3-969a-819f8012f37712019-08-06
63323-411-25ML - Milliliter63323-4112f594f2f-e37d-42fc-aa5d-190eae65263e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-411MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 8 package rows20240806_a91ce254-14a3-4cbf-8ab8-5da252aa3fdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311700midazolam 1 MG/ML Injectable SolutionPSNa91ce254-14a3-4cbf-8ab8-5da252aa3fdc7
311702midazolam 5 MG/ML Injectable SolutionPSNa91ce254-14a3-4cbf-8ab8-5da252aa3fdc7
311700midazolam 1 MG/ML Injectable SolutionSCDa91ce254-14a3-4cbf-8ab8-5da252aa3fdc7
311702midazolam 5 MG/ML Injectable SolutionSCDa91ce254-14a3-4cbf-8ab8-5da252aa3fdc7
311700midazolam (as midazolam hydrochloride) 1 MG/ML Injectable SolutionSYa91ce254-14a3-4cbf-8ab8-5da252aa3fdc7
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSYa91ce254-14a3-4cbf-8ab8-5da252aa3fdc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-411-106332304111010 VIAL in 1 TRAY (63323-411-10) / 10 mL in 1 VIAL (63323-411-13) 10 vial2000-07-140000-00-00NoNoCurrent
63323-411-126332304111225 VIAL in 1 TRAY (63323-411-12) / 2 mL in 1 VIAL (63323-411-15) 25 vial2000-07-140000-00-00NoNoCurrent
63323-411-136332304111310 mL in 1 VIAL10 mlHistorical
63323-411-15633230411152 mL in 1 VIAL2 mlHistorical
63323-411-18633230411185 mL in 1 VIAL5 mlHistorical
63323-411-22633230411222 mL in 1 VIAL2 mlHistorical
63323-411-256332304112525 VIAL in 1 TRAY (63323-411-25) / 5 mL in 1 VIAL (63323-411-18) 25 vial2000-07-140000-00-00NoNoCurrent
63323-411-276332304112725 VIAL in 1 TRAY (63323-411-27) / 2 mL in 1 VIAL (63323-411-22) 25 vial2025-01-06NoNoCurrent