FDA.reportPublic FDA data

Midazolam

Product NDC
0641-6218
11-digit product format
006416218
Labeler code
0641
Product ID
0641-6218_c7078d4a-0f37-4305-b20c-0a8f17382963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA212847
Marketing category
ANDA
Marketing start
2024-03-29
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW7TTW573JJ
Rxcui998211, 1551393, 1551395

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
0641-6218-01Midazolam1 mL in 1 SYRINGEINJECTION14
0641-6218-10Midazolam10 in 1 CARTONINJECTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6218MIDAZOLAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20240331_51c8bfa4-5c78-4b7a-9ffb-8f00828acadc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551393midazolam 10 MG in 2 ML Prefilled SyringePSN51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4
998211midazolam 2 MG in 2 ML Prefilled SyringePSN51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4
1551395midazolam 5 MG in 1 ML Prefilled SyringePSN51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4
15513951 ML midazolam 5 MG/ML Prefilled SyringeSCD51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4
9982112 ML midazolam 1 MG/ML Prefilled SyringeSCD51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4
15513932 ML midazolam 5 MG/ML Prefilled SyringeSCD51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4
1551393midazolam (as midazolam hydrochloride) 10 MG per 2 ML Prefilled SyringeSY51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4
998211midazolam (as midazolam hydrochloride) 2 MG per 2 ML Prefilled SyringeSY51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4
1551395midazolam (as midazolam hydrochloride) 5 MG per 1 ML Prefilled SyringeSY51c8bfa4-5c78-4b7a-9ffb-8f00828acadc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6218-01006416218011 mL in 1 SYRINGE1 mlHistorical
0641-6218-100064162181010 SYRINGE in 1 CARTON (0641-6218-10) / 1 mL in 1 SYRINGE (0641-6218-01) 10 syringe2024-03-29NoNoCurrent