FDA.reportPublic FDA data

Midazolam

Product NDC
0409-2305
11-digit product format
004092305
Labeler code
0409
Product ID
0409-2305_74093865-864a-49e8-99b9-c985fe72afb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDAZOLAM HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA075857
Marketing category
ANDA
Marketing start
2005-08-17
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Midazolam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW7TTW573JJ
Rxcui1666798, 1666800, 1666814, 1666823

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
0409-2305-04Midazolam5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION534
0409-2305-05Midazolam10 in 1 CARTONINJECTION, SOLUTION1034
0409-2305-16Midazolam2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION234
0409-2305-17Midazolam25 in 1 TRAYINJECTION, SOLUTION2534
0409-2305-50MIDAZOLAM10 in 1 CARTONINJECTION, SOLUTION1018
0409-2305-55MIDAZOLAM5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2305-02ML - Milliliter0409-230598253dc2-cea7-4525-a3ba-8501b7f6c5e812012-07-24
0409-2305-04ML - Milliliter0409-2305de4bce48-0fc0-4223-a261-039c00a587b612020-02-13
0409-2305-05ML - Milliliter0409-230512e3eb93-2779-475c-8b8e-bc237591d2ba12012-07-24
0409-2305-16ML - Milliliter0409-23055e7e3c5f-a976-4520-a459-62f2ff11d86412020-02-13
0409-2305-17ML - Milliliter0409-2305f88f3d1d-297c-4e57-870c-977b5c1ce9d512012-07-24
0409-2305-21ML - Milliliter0409-2305c87b68e3-5cb3-470e-bb01-4524645ba74b12012-07-24
0409-2305-49ML - Milliliter0409-2305fab609b7-2497-4d17-b98f-d436db9dab6c12012-07-24
0409-2305-50ML - Milliliter0409-2305a54d35d2-1118-4ee2-93bf-46a2179969e012012-07-24
0409-2305-55ML - Milliliter0409-2305419c9af9-b6c3-42b3-bbe5-5d5ae95028ca12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2305MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]31Current NDC, Legacy NDC, 4 package rows20250129_1abda8b8-48a8-4995-af86-39220d1aa240.zip
0409-2305MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]16Current NDC, Legacy NDC, 2 package rows20241201_b95415fa-17c2-42ab-a6b0-e628d01c94ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666823midazolam 10 MG in 2 ML InjectionPSN1abda8b8-48a8-4995-af86-39220d1aa24034
1666798midazolam 2 MG in 2 ML InjectionPSN1abda8b8-48a8-4995-af86-39220d1aa24034
1666814midazolam 5 MG in 1 ML InjectionPSN1abda8b8-48a8-4995-af86-39220d1aa24034
1666800midazolam 5 MG in 5 ML InjectionPSN1abda8b8-48a8-4995-af86-39220d1aa24034
16668141 ML midazolam 5 MG/ML InjectionSCD1abda8b8-48a8-4995-af86-39220d1aa24034
16667982 ML midazolam 1 MG/ML InjectionSCD1abda8b8-48a8-4995-af86-39220d1aa24034
16668232 ML midazolam 5 MG/ML InjectionSCD1abda8b8-48a8-4995-af86-39220d1aa24034
16668005 ML midazolam 1 MG/ML InjectionSCD1abda8b8-48a8-4995-af86-39220d1aa24034
1666814midazolam (as midazolam hydrochloride) 5 MG per 1 ML InjectionSY1abda8b8-48a8-4995-af86-39220d1aa24034
1666823midazolam 10 MG per 2 ML InjectionSY1abda8b8-48a8-4995-af86-39220d1aa24034
1666798midazolam 2 MG per 2 ML InjectionSY1abda8b8-48a8-4995-af86-39220d1aa24034
1666800midazolam 5 MG per 5 ML InjectionSY1abda8b8-48a8-4995-af86-39220d1aa24034
1666823midazolam 10 MG in 2 ML InjectionPSNb95415fa-17c2-42ab-a6b0-e628d01c94ed18
1666814midazolam 5 MG in 1 ML InjectionPSNb95415fa-17c2-42ab-a6b0-e628d01c94ed18
1666800midazolam 5 MG in 5 ML InjectionPSNb95415fa-17c2-42ab-a6b0-e628d01c94ed18
16668141 ML midazolam 5 MG/ML InjectionSCDb95415fa-17c2-42ab-a6b0-e628d01c94ed18
16668232 ML midazolam 5 MG/ML InjectionSCDb95415fa-17c2-42ab-a6b0-e628d01c94ed18
16668005 ML midazolam 1 MG/ML InjectionSCDb95415fa-17c2-42ab-a6b0-e628d01c94ed18
1666814midazolam (as midazolam hydrochloride) 5 MG per 1 ML InjectionSYb95415fa-17c2-42ab-a6b0-e628d01c94ed18
1666823midazolam 10 MG per 2 ML InjectionSYb95415fa-17c2-42ab-a6b0-e628d01c94ed18
1666800midazolam 5 MG per 5 ML InjectionSYb95415fa-17c2-42ab-a6b0-e628d01c94ed18
1666798midazolam 2 MG in 2 ML InjectionPSNcbedf0bf-82a4-4214-96d5-01ac35e101f07
16667982 ML midazolam 1 MG/ML InjectionSCDcbedf0bf-82a4-4214-96d5-01ac35e101f07
1666798midazolam 2 MG per 2 ML InjectionSYcbedf0bf-82a4-4214-96d5-01ac35e101f07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2305-04004092305045 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0409-2305-050040923050510 VIAL, SINGLE-DOSE in 1 CARTON (0409-2305-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2305-04) 2005-12-160000-00-00NoNoCurrent
0409-2305-16004092305162 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0409-2305-170040923051725 VIAL, SINGLE-DOSE in 1 TRAY (0409-2305-17) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-2305-16) 2010-06-290000-00-00NoNoCurrent
0409-2305-500040923055010 VIAL, SINGLE-DOSE in 1 CARTON (0409-2305-50) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2305-55) 2005-09-220000-00-00NoNoCurrent
0409-2305-55004092305555 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical