posaconazole

Product NDC
72205-168
11-digit product format
722050168
Labeler code
72205
Product ID
72205-168_0bdf77ae-3639-49c1-b7c7-533f9d073084
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
posaconazole
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA218434
Marketing category
ANDA
Marketing start
2025-02-24
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-168-60posaconazole60 in 1 BOTTLETABLET, COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-168-60EA - Each72205-1684e80913f-0b84-4bbf-afd6-b61cdfd2fd3d12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-168POSACONAZOLE TABLET, COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 1 package rows20250311_0bdf77ae-3639-49c1-b7c7-533f9d073084.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSN0bdf77ae-3639-49c1-b7c7-533f9d0730841
1482908posaconazole 100 MG Delayed Release Oral TabletSCD0bdf77ae-3639-49c1-b7c7-533f9d0730841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-168-607220501686060 TABLET, COATED in 1 BOTTLE (72205-168-60) 2025-04-01NoNoCurrent