FDA.reportPublic FDA data

Posaconazole

Product NDC
72162-2243
11-digit product format
721622243
Labeler code
72162
Product ID
72162-2243_01fd7009-ab61-484a-bb31-57f98527d179
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Posaconazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216488
Marketing category
ANDA
Marketing start
2023-09-15
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2243-2Posaconazole20 in 1 BOTTLETABLET, DELAYED RELEASE20101
72162-2243-6Posaconazole60 in 1 BOTTLETABLET, DELAYED RELEASE60101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2243-2EA - Each72162-2243086af85c-3deb-466b-81c6-28c71c82d5c512024-08-12
72162-2243-6EA - Each72162-22434069ee9b-ca35-4527-93f4-333af747f4ec12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2243POSACONAZOLE TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240718_d2daba09-f1c2-4764-a567-1291be4892b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSNd2daba09-f1c2-4764-a567-1291be4892b9101
1482908posaconazole 100 MG Delayed Release Oral TabletSCDd2daba09-f1c2-4764-a567-1291be4892b9101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2243-27216222430220 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2243-2) 2024-01-19NoNoHistorical
72162-2243-67216222430660 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2243-6) 2024-01-19NoNoHistorical