FDA.reportPublic FDA data

Midazolam

Product NDC
63323-412
11-digit product format
633230412
Labeler code
63323
Product ID
63323-412_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
2000-07-10
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
63323-412-02Midazolam10 in 1 TRAYINJECTION, SOLUTION107
63323-412-03Midazolam2 mL in 1 VIALINJECTION, SOLUTION27
63323-412-05Midazolam10 in 1 TRAYINJECTION, SOLUTION107
63323-412-06Midazolam5 mL in 1 VIALINJECTION, SOLUTION57
63323-412-10Midazolam10 in 1 TRAYINJECTION, SOLUTION107
63323-412-13Midazolam10 mL in 1 VIALINJECTION, SOLUTION107
63323-412-18Midazolam1 mL in 1 VIALINJECTION, SOLUTION17
63323-412-25Midazolam25 in 1 TRAYINJECTION, SOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-412-02ML - Milliliter63323-4128efc1412-9341-407f-8f72-b8f5b766deea12013-02-13
63323-412-03ML - Milliliter63323-4124b1d71cf-cbc3-4acf-b5f8-e874d80e51f012019-10-07
63323-412-05ML - Milliliter63323-412882430ae-195a-4c1f-bcc3-4d84f685c3b912013-02-13
63323-412-06ML - Milliliter63323-4121e201941-c71f-44ac-9e1f-fc7d1310890512019-10-07
63323-412-10ML - Milliliter63323-412f3d9824f-c81d-4c0a-a1d5-19edfce62fc712013-02-13
63323-412-13ML - Milliliter63323-412ec1f0dac-d3c3-48d1-a934-beb19d3c683012019-10-07
63323-412-18ML - Milliliter63323-41253679acb-42ac-40d1-a457-69fdf9d7a05c12019-10-07
63323-412-25ML - Milliliter63323-412d0d9cb42-66d0-4cd5-88dc-0bdf5e1dc61b12013-02-13

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
63323-412MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 8 package rows20240806_a91ce254-14a3-4cbf-8ab8-5da252aa3fdc.zip
63323-412MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC20241031_09daf48f-1d44-4b7b-bb53-bd5635b93ca6.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
63323-412-00633230412001 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-412-00) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2017-03-280000-00-00NoNoCurrent
63323-412-026332304120210 VIAL in 1 TRAY (63323-412-02) / 2 mL in 1 VIAL (63323-412-03) 10 vial2000-07-100000-00-00NoNoCurrent
63323-412-03633230412032 mL in 1 VIAL2 mlHistorical
63323-412-056332304120510 in 1 TRAYHistorical
63323-412-06633230412065 mL in 1 VIAL5 mlHistorical
63323-412-106332304121010 VIAL in 1 TRAY (63323-412-10) / 10 mL in 1 VIAL (63323-412-13) 10 vial2000-07-100000-00-00NoNoCurrent
63323-412-136332304121310 mL in 1 VIAL10 mlHistorical
63323-412-18633230412181 mL in 1 VIAL1 mlHistorical
63323-412-256332304122525 VIAL in 1 TRAY (63323-412-25) / 1 mL in 1 VIAL (63323-412-18) 25 vial2000-07-100000-00-00NoNoCurrent