POSACONAZOLE

Product NDC
59651-596
11-digit product format
596510596
Labeler code
59651
Product ID
59651-596_8c734106-02cb-47c6-89fd-e4fe1cdff758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POSACONAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217119
Marketing category
ANDA
Marketing start
2024-07-18
Substance
POSACONAZOLE
Active strength
100 mg/1
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
POSACONAZOLE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6TK1G07BHZ
Rxcui1482908

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
59651-596-60POSACONAZOLE60 in 1 BOTTLETABLET, DELAYED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-596POSACONAZOLE TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]2Current NDC, 1 package rows20241123_f8a26673-261c-4e8e-b1e1-9e23aaf7f285.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSNf8a26673-261c-4e8e-b1e1-9e23aaf7f2852
1482908posaconazole 100 MG Delayed Release Oral TabletSCDf8a26673-261c-4e8e-b1e1-9e23aaf7f2852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-596-605965105966060 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-596-60) 2024-07-18NoNoCurrent