FDA.reportPublic FDA data

POSACONAZOLE

Product NDC
0527-2133
11-digit product format
005272133
Labeler code
0527
Product ID
0527-2133_291b0655-036f-4073-a475-c33a411db178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Posaconazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lannett Company Inc.
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
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
0527-2133-30POSACONAZOLE24 in 1 CARTONTABLET, DELAYED RELEASE2415
0527-2133-35POSACONAZOLE60 in 1 BOTTLETABLET, DELAYED RELEASE6015
0527-2133-43POSACONAZOLE1000 in 1 BOTTLETABLET, DELAYED RELEASE100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-2133-35EA - Each0527-21333c3702d4-5731-445a-a3d5-c222d8c5feaf12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2133POSACONAZOLE TABLET, DELAYED RELEASE [LANNETT COMPANY INC.]15Current NDC, Legacy NDC, 3 package rows20250104_94a9b028-a2bc-4f41-884d-2d6c536881fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSN94a9b028-a2bc-4f41-884d-2d6c536881fc15
1482908posaconazole 100 MG Delayed Release Oral TabletSCD94a9b028-a2bc-4f41-884d-2d6c536881fc15
1482908posaconazole 100 MG Delayed Release Oral TabletPSNe809a31a-09da-46bf-bcaa-f34b7f3b54a36
1482908posaconazole 100 MG Delayed Release Oral TabletSCDe809a31a-09da-46bf-bcaa-f34b7f3b54a36
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-2133-300052721333024 TABLET, DELAYED RELEASE in 1 CARTON (0527-2133-30) 2021-01-310000-00-00NoNoCurrent
0527-2133-350052721333560 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-35) 2019-08-280000-00-00NoNoCurrent
0527-2133-43005272133431000 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-43) 2019-08-280000-00-00NoNoCurrent