FDA.reportPublic FDA data

midazolam

Product NDC
25021-661
11-digit product format
250210661
Labeler code
25021
Product ID
25021-661_002ea282-09ba-4d79-8bd1-94c9859f442b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midazolam hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090850
Marketing category
ANDA
Marketing start
2012-03-19
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
Rxcui311702

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
25021-661-10midazolam10 mL in 1 VIALINJECTION, SOLUTION1014
25021-661-10midazolam10 in 1 CARTONINJECTION, SOLUTION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-661-05ML - Milliliter25021-661728fb4d7-edf9-4244-a544-cb5f2928534212012-07-24
25021-661-10ML - Milliliter25021-6614e2f0cff-ddbc-4b7a-b859-eb7e899e8ac612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
midazolam hydrochlorideACTIVE INGREDIENTW7TTW573JJMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS]10
midazolamACTIVE MOIETYR60L0SM5BCMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS]10
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS]10
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS]10
sodium hydroxideINACTIVE INGREDIENT55X04QC32IMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-661MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]14Current NDC, 2 package rows20231108_880cac48-5c0f-49a9-8aef-3c9770bf5d84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311702midazolam 5 MG/ML Injectable SolutionPSN880cac48-5c0f-49a9-8aef-3c9770bf5d8414
311702midazolam 5 MG/ML Injectable SolutionSCD880cac48-5c0f-49a9-8aef-3c9770bf5d8414
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSY880cac48-5c0f-49a9-8aef-3c9770bf5d8414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-661-102502106611010 VIAL in 1 CARTON (25021-661-10) / 10 mL in 1 VIAL10 vial2012-03-19NoNoHistorical