FDA.reportPublic FDA data

Midazolam

Product NDC
76045-211
11-digit product format
760450211
Labeler code
76045
Product ID
76045-211_ec9c9aee-b95f-4645-bf17-df7f1e3967d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203460
Marketing category
ANDA
Marketing start
2021-04-16
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
2 mg/2mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
4cc03496-da49-494d-b71d-757fe6737fa2Product name120230717
06641162-4d53-492d-8ff2-5951a469060fProduct name120230420
46ca420c-e4d5-4e6c-9b2f-cea269a262e8Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b84efe2b-3f4e-4b09-90f9-1d24a61ec30eProduct name120190808
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16Product name120181220
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
31f18c4e-1938-700a-43de-b9e218c36edcProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76045-211-00Midazolam1 in 1 BLISTER PACKINJECTION, SOLUTION116
76045-211-00Midazolam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION216
76045-211-20Midazolam24 in 1 CARTONINJECTION, SOLUTION2416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-211-00ML - Milliliter76045-21192d515ec-203d-4d46-b1dd-068b45c888bb12025-05-14
76045-211-20ML - Milliliter76045-211bbc28f32-0448-4635-a3b3-a8ed1f08cfb312025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Midazolam HydrochlorideACTIVE INGREDIENTW7TTW573JJMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]1
MidazolamACTIVE MOIETYR60L0SM5BCMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]1
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-211MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]16Current NDC, Legacy NDC, 3 package rows20240119_1cc9ba6e-fa1b-405e-9de8-720c567b2a73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551393midazolam 10 MG in 2 ML Prefilled SyringePSN1cc9ba6e-fa1b-405e-9de8-720c567b2a7316
998211midazolam 2 MG in 2 ML Prefilled SyringePSN1cc9ba6e-fa1b-405e-9de8-720c567b2a7316
1551395midazolam 5 MG in 1 ML Prefilled SyringePSN1cc9ba6e-fa1b-405e-9de8-720c567b2a7316
15513951 ML midazolam 5 MG/ML Prefilled SyringeSCD1cc9ba6e-fa1b-405e-9de8-720c567b2a7316
9982112 ML midazolam 1 MG/ML Prefilled SyringeSCD1cc9ba6e-fa1b-405e-9de8-720c567b2a7316
15513932 ML midazolam 5 MG/ML Prefilled SyringeSCD1cc9ba6e-fa1b-405e-9de8-720c567b2a7316
1551393midazolam (as midazolam hydrochloride) 10 MG per 2 ML Prefilled SyringeSY1cc9ba6e-fa1b-405e-9de8-720c567b2a7316
998211midazolam (as midazolam hydrochloride) 2 MG per 2 ML Prefilled SyringeSY1cc9ba6e-fa1b-405e-9de8-720c567b2a7316
1551395midazolam (as midazolam hydrochloride) 5 MG per 1 ML Prefilled SyringeSY1cc9ba6e-fa1b-405e-9de8-720c567b2a7316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76045-211-00760450211001 in 1 BLISTER PACKHistorical
76045-211-207604502112024 BLISTER PACK in 1 CARTON (76045-211-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00) / 2 mL in 1 SYRINGE, GLASS24 blister pack2021-04-160000-00-00NoNoCurrent