FDA.reportPublic FDA data

Midazolam in Sodium Chloride

Product NDC
25021-688
11-digit product format
250210688
Labeler code
25021
Product ID
25021-688_44922f28-68c0-45c6-ad4c-0cc7706a78b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA218993
Marketing category
ANDA
Marketing start
2025-04-15
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 in Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW7TTW573JJ
Rxcui2541170, 2541171

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
25021-688-82Midazolam in Sodium Chloride50 mL in 1 BAGINJECTION, SOLUTION501
25021-688-82Midazolam in Sodium Chloride10 in 1 CARTONINJECTION, SOLUTION101
25021-688-87Midazolam in Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION1001
25021-688-87Midazolam in Sodium Chloride20 in 1 CARTONINJECTION, SOLUTION201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-688-82ML - Milliliter25021-688f2a7504b-bbae-45c0-8c8c-a634b0ae74ef12025-06-13
25021-688-87ML - Milliliter25021-6889887586b-a487-4db0-9a53-51345dd03d5212025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-688MIDAZOLAM IN SODIUM CHLORIDE (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 4 package rows20250416_c546cfd4-4f2b-4b94-aa47-995595f1a146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2541171midazolam 100 MG in 100 mL InjectionPSNc546cfd4-4f2b-4b94-aa47-995595f1a1461
2541170midazolam 50 MG in 50 mL InjectionPSNc546cfd4-4f2b-4b94-aa47-995595f1a1461
2541171100 ML midazolam 1 MG/ML InjectionSCDc546cfd4-4f2b-4b94-aa47-995595f1a1461
254117050 ML midazolam 1 MG/ML InjectionSCDc546cfd4-4f2b-4b94-aa47-995595f1a1461
2541171midazolam 100 MG per 100 ML InjectionSYc546cfd4-4f2b-4b94-aa47-995595f1a1461
2541170midazolam 50 MG per 50 ML InjectionSYc546cfd4-4f2b-4b94-aa47-995595f1a1461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-688-822502106888210 BAG in 1 CARTON (25021-688-82) / 50 mL in 1 BAG10 bag2025-04-15NoNoHistorical
25021-688-872502106888720 BAG in 1 CARTON (25021-688-87) / 100 mL in 1 BAG20 bag2025-04-15NoNoHistorical