FDA.reportPublic FDA data

Midazolam

Product NDC
0409-2596
11-digit product format
004092596
Labeler code
0409
Product ID
0409-2596_6c075a2d-b68b-41a7-aa0c-bcf9894e3f76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIDAZOLAM HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA075293
Marketing category
ANDA
Marketing start
2005-11-03
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 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 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2596-03Midazolam10 in 1 CARTONINJECTION, SOLUTION1031
0409-2596-05Midazolam10 in 1 CARTONINJECTION, SOLUTION1031
0409-2596-13Midazolam5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION531
0409-2596-15Midazolam10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2596-03ML - Milliliter0409-2596665b2b30-f374-49e8-98db-39812f85c70812012-07-24
0409-2596-05ML - Milliliter0409-25967267b9f0-b727-45bb-a1ad-d762f8f31d4712012-07-24
0409-2596-13ML - Milliliter0409-2596747a5c15-0a17-4ec3-b190-7371030b92ae12020-02-13
0409-2596-15ML - Milliliter0409-25963fcca094-4902-444f-9cbc-d6c066fa7d2b12020-02-13
0409-2596-52ML - Milliliter0409-259658bbe8c4-7390-41b7-8e38-e5240567f40d12012-07-24
0409-2596-53ML - Milliliter0409-2596afed244b-6725-4e9f-a762-cba1dc1db08a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2596MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]28Current NDC, Legacy NDC, 4 package rows20241220_affecd4d-1f78-4bbe-5a8d-86849bbdc520.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311700midazolam 1 MG/ML Injectable SolutionPSNaffecd4d-1f78-4bbe-5a8d-86849bbdc52031
311702midazolam 5 MG/ML Injectable SolutionPSNaffecd4d-1f78-4bbe-5a8d-86849bbdc52031
311700midazolam 1 MG/ML Injectable SolutionSCDaffecd4d-1f78-4bbe-5a8d-86849bbdc52031
311702midazolam 5 MG/ML Injectable SolutionSCDaffecd4d-1f78-4bbe-5a8d-86849bbdc52031
311700midazolam (as midazolam hydrochloride) 1 MG/ML Injectable SolutionSYaffecd4d-1f78-4bbe-5a8d-86849bbdc52031
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSYaffecd4d-1f78-4bbe-5a8d-86849bbdc52031
311702midazolam 5 MG/ML Injectable SolutionPSN5e85e477-d483-4345-8d7b-d7dcdc3e065210
311702midazolam 5 MG/ML Injectable SolutionSCD5e85e477-d483-4345-8d7b-d7dcdc3e065210
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSY5e85e477-d483-4345-8d7b-d7dcdc3e065210
311702midazolam 5 MG/ML Injectable SolutionPSN90f7b7f6-d0fd-40af-bbfa-70b152e3e27c6
311702midazolam 5 MG/ML Injectable SolutionSCD90f7b7f6-d0fd-40af-bbfa-70b152e3e27c6
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSY90f7b7f6-d0fd-40af-bbfa-70b152e3e27c6
311702midazolam 5 MG/ML Injectable SolutionPSN249af7c9-8e3a-4fae-aa78-46bbeab44fe12
311702midazolam 5 MG/ML Injectable SolutionSCD249af7c9-8e3a-4fae-aa78-46bbeab44fe12
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSY249af7c9-8e3a-4fae-aa78-46bbeab44fe12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2596-030040925960310 VIAL, MULTI-DOSE in 1 CARTON (0409-2596-03) / 5 mL in 1 VIAL, MULTI-DOSE (0409-2596-13) 2005-11-030000-00-00NoNoCurrent
0409-2596-050040925960510 VIAL, MULTI-DOSE in 1 CARTON (0409-2596-05) / 10 mL in 1 VIAL, MULTI-DOSE (0409-2596-15) 2006-01-120000-00-00NoNoCurrent
0409-2596-13004092596135 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
0409-2596-150040925961510 mL in 1 VIAL, MULTI-DOSE10 mlHistorical