Posaconazole

Product NDC
43598-470
11-digit product format
435980470
Labeler code
43598
Product ID
43598-470_771b0f10-3966-f387-3306-6efdbf95d37e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Posaconazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA212500
Marketing category
ANDA
Marketing start
2022-04-07
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
43598-470-60Posaconazole60 in 1 BOTTLETABLET, DELAYED RELEASE6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-470-60EA - Each43598-4700a31b8cf-f56a-4d86-9255-8ee0b441270212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-470POSACONAZOLE TABLET, DELAYED RELEASE [DR.REDDYS LABORATORIES INC]14Current NDC, Legacy NDC, 1 package rows20241211_d8d8dd03-46b5-bd26-bb27-7ca31d8c3326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSNd8d8dd03-46b5-bd26-bb27-7ca31d8c332615
1482908posaconazole 100 MG Delayed Release Oral TabletSCDd8d8dd03-46b5-bd26-bb27-7ca31d8c332615
1482908posaconazole 100 MG Delayed Release Oral TabletPSNde95df83-a495-1900-e053-2995a90abf242
1482908posaconazole 100 MG Delayed Release Oral TabletSCDde95df83-a495-1900-e053-2995a90abf242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-470-604359804706060 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-470-60) 2022-04-070000-00-00NoNoCurrent