FDA.reportPublic FDA data

POSACONAZOLE

Product NDC
17856-2133
11-digit product format
178562133
Labeler code
17856
Product ID
17856-2133_4fea6190-d259-a7e3-e063-6394a90aa93f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Posaconazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA212411
Marketing category
ANDA
Marketing start
2019-08-28
Substance
POSACONAZOLE
Active strength
100 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
POSACONAZOLE
Listing expiration
2027-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-2133-12024-05-09C16284748780-11030e365-658a-111a-e063-dadaa90a10e2POSACONAZOLE DELAYED-RELEASE TABLETS These highlights do not include all the information needed to use POSACONAZOLE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for POSACONAZOLE DELAYED-RELEASE TABLETS. POSACONAZOLE delayed-release tablets, for oral use Initial U.S. Approval: 2006
17856-2133-12024-01-30C16284748780-11030e365-658a-111a-e063-dadaa90a10e2POSACONAZOLE DELAYED-RELEASE TABLETS These highlights do not include all the information needed to use POSACONAZOLE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for POSACONAZOLE DELAYED-RELEASE TABLETS. POSACONAZOLE delayed-release tablets, for oral use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-2133-1POSACONAZOLE100 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE1004
17856-2133-2POSACONAZOLE1 in 1 POUCHTABLET, DELAYED RELEASE14
17856-2133-5POSACONAZOLE1 in 1 POUCHTABLET, DELAYED RELEASE14
17856-2133-5POSACONAZOLE59 in 1 BOXTABLET, DELAYED RELEASE594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-2133POSACONAZOLE TABLET, DELAYED RELEASE [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 4 package rows20240510_dfbc636f-d8a7-4232-a6b0-cda49caadc9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSNdfbc636f-d8a7-4232-a6b0-cda49caadc9b4
1482908posaconazole 100 MG Delayed Release Oral TabletSCDdfbc636f-d8a7-4232-a6b0-cda49caadc9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-2133-117856213301100 POUCH in 1 BOX, UNIT-DOSE (17856-2133-1) / 1 TABLET, DELAYED RELEASE in 1 POUCH (17856-2133-2) 100 pouch2024-05-090000-00-00NoNoCurrent
17856-2133-2178562133021 in 1 POUCHHistorical
17856-2133-51785621330559 POUCH in 1 BOX (17856-2133-5) / 1 TABLET, DELAYED RELEASE in 1 POUCH59 pouch2026-04-20NoNoHistorical