FDA.reportPublic FDA data

Posaconazole

Product NDC
69238-1476
11-digit product format
692381476
Labeler code
69238
Product ID
69238-1476_3f266ed7-06f9-48bf-a520-787aeb4e111c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Posaconazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA216626
Marketing category
ANDA
Marketing start
2022-12-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1476-3Posaconazole30 in 1 BOTTLETABLET, DELAYED RELEASE309
69238-1476-6Posaconazole60 in 1 BOTTLETABLET, DELAYED RELEASE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1476-6EA - Each69238-14769cc5265b-8326-4e0c-81df-3cc22497e36d12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1476POSACONAZOLE TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, 2 package rows20241211_5f795eca-7a03-4c91-9a0e-c1235791b665.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSN5f795eca-7a03-4c91-9a0e-c1235791b6659
1482908posaconazole 100 MG Delayed Release Oral TabletSCD5f795eca-7a03-4c91-9a0e-c1235791b6659
1482908posaconazole 100 MG Delayed Release Oral TabletPSNf9c81d88-8e2c-fa53-e053-6394a90ac5c43
1482908posaconazole 100 MG Delayed Release Oral TabletSCDf9c81d88-8e2c-fa53-e053-6394a90ac5c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69238-1476-36923814760330 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-3) 2022-12-30NoNoCurrent
69238-1476-66923814760660 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-6) 2022-12-30NoNoCurrent