FDA.reportPublic FDA data

Midazolam hydrochloride

Product NDC
55648-763
11-digit product format
556480763
Labeler code
55648
Product ID
55648-763_78b2a31c-22dd-42f7-8085-c32010d52256
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Wockhardt Limited
Application
ANDA078141
Marketing category
ANDA
Marketing start
2008-05-30
Marketing end
0000-00-00
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-763-012020-01-31C16284748780-19d75b9d1-1713-f424-e053-dadaa90a57ceMIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-763-022020-01-31C16284748780-19d75b9d1-1713-f424-e053-dadaa90a57ceMIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-763-032020-01-31C16284748780-19d75b9d1-1713-f424-e053-dadaa90a57ceMIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-763-042020-01-31C16284748780-19d75b9d1-1713-f424-e053-dadaa90a57ceMIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-763-052020-01-31C16284748780-19d75b9d1-1713-f424-e053-dadaa90a57ceMIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-763-062020-01-31C16284748780-19d75b9d1-1713-f424-e053-dadaa90a57ceMIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-763-072020-01-31C16284748780-19d75b9d1-1713-f424-e053-dadaa90a57ceMIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-763-082020-01-31C16284748780-19d75b9d1-1713-f424-e053-dadaa90a57ceMIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-763-01Midazolam hydrochloride10 in 1 CARTONINJECTION101
55648-763-02Midazolam hydrochloride10 in 1 CARTONINJECTION101
55648-763-03Midazolam hydrochloride10 in 1 CARTONINJECTION101
55648-763-04Midazolam hydrochloride10 in 1 CARTONINJECTION101
55648-763-05Midazolam hydrochloride25 in 1 CARTONINJECTION251
55648-763-06Midazolam hydrochloride25 in 1 CARTONINJECTION251
55648-763-07Midazolam hydrochloride25 in 1 CARTONINJECTION251
55648-763-08Midazolam hydrochloride25 in 1 CARTONINJECTION251
55648-763-09Midazolam hydrochloride1 mL in 1 VIALINJECTION11
55648-763-10Midazolam hydrochloride2 mL in 1 VIALINJECTION21
55648-763-11Midazolam hydrochloride5 mL in 1 VIALINJECTION51
55648-763-12Midazolam hydrochloride10 mL in 1 VIALINJECTION101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-763MIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1Legacy NDC, 12 package rows20121119_19fbdc82-a727-4345-b67e-d0fd620defca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311700midazolam 1 MG/ML Injectable SolutionPSN19fbdc82-a727-4345-b67e-d0fd620defca1
311702midazolam 5 MG/ML Injectable SolutionPSN19fbdc82-a727-4345-b67e-d0fd620defca1
311700midazolam 1 MG/ML Injectable SolutionSCD19fbdc82-a727-4345-b67e-d0fd620defca1
311702midazolam 5 MG/ML Injectable SolutionSCD19fbdc82-a727-4345-b67e-d0fd620defca1
311700midazolam (as midazolam hydrochloride) 1 MG/ML Injectable SolutionSY19fbdc82-a727-4345-b67e-d0fd620defca1
311702midazolam (as midazolam hydrochloride) 5 MG/ML Injectable SolutionSY19fbdc82-a727-4345-b67e-d0fd620defca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55648-763-015564807630110 in 1 CARTONHistorical
55648-763-025564807630210 in 1 CARTONHistorical
55648-763-035564807630310 in 1 CARTONHistorical
55648-763-045564807630410 in 1 CARTONHistorical
55648-763-055564807630525 in 1 CARTONHistorical
55648-763-065564807630625 in 1 CARTONHistorical
55648-763-075564807630725 in 1 CARTONHistorical
55648-763-085564807630825 in 1 CARTONHistorical
55648-763-09556480763091 mL in 1 VIAL1 mlHistorical
55648-763-10556480763102 mL in 1 VIAL2 mlHistorical
55648-763-11556480763115 mL in 1 VIAL5 mlHistorical
55648-763-125564807631210 mL in 1 VIAL10 mlHistorical