POSACONAZOLE

Product NDC
31722-370
11-digit product format
317220370
Labeler code
31722
Product ID
31722-370_2cfdafa2-b1b9-0758-e063-6394a90ac7f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POSACONAZOLE
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219057
Marketing category
ANDA
Marketing start
2024-12-23
Substance
POSACONAZOLE
Active strength
18 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
POSACONAZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POSACONAZOLE18 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6TK1G07BHZ
Rxcui1492043

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc1eab98-5691-4d9a-82e4-7e2823a44fa6Product name920251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-370-31POSACONAZOLE1 in 1 CARTONSOLUTION11
31722-370-31POSACONAZOLE16.7 mL in 1 VIAL, GLASSSOLUTION16.71

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-370-31ML - Milliliter31722-370dc01836c-b454-4e91-ace1-76433f1e98e912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-370POSACONAZOLE (POSACONAZOLE) SOLUTION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250201_c551e121-d5fc-4b35-ba9f-72ce3a314fdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1492043posaconazole 300 MG in 16.7 ML InjectionPSNc551e121-d5fc-4b35-ba9f-72ce3a314fdc1
149204316.7 ML posaconazole 18 MG/ML InjectionSCDc551e121-d5fc-4b35-ba9f-72ce3a314fdc1
1492043posaconazole 300 MG per 16.7 ML InjectionSYc551e121-d5fc-4b35-ba9f-72ce3a314fdc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-370-31317220370311 VIAL, GLASS in 1 CARTON (31722-370-31) / 16.7 mL in 1 VIAL, GLASS2024-12-23NoNoCurrent