Posaconazole

Product NDC
60687-523
11-digit product format
606870523
Labeler code
60687
Product ID
60687-523_43cf3b42-f8bc-4881-e063-6294a90a3bdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Posaconazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA212411
Marketing category
ANDA
Marketing start
2020-06-11
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
60687-523-11Posaconazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE16
60687-523-21Posaconazole30 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE306
60687-523-94Posaconazole20 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-523-11EA - Each60687-523f091a6b5-82e0-44a7-a501-c98857285c8e12020-07-13
60687-523-21EA - Each60687-5237888a6f2-265b-4da7-bb86-1665b4f5254812020-07-13
60687-523-94EA - Each60687-52377875c46-a109-4133-be89-952df69a4b5b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-523POSACONAZOLE TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 3 package rows20241109_e809a31a-09da-46bf-bcaa-f34b7f3b54a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSNe809a31a-09da-46bf-bcaa-f34b7f3b54a36
1482908posaconazole 100 MG Delayed Release Oral TabletSCDe809a31a-09da-46bf-bcaa-f34b7f3b54a36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-523-11606870523111 in 1 BLISTER PACKHistorical
60687-523-216068705232130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-523-21) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-523-11) 30 blister pack2020-06-110000-00-00NoNoCurrent
60687-523-946068705239420 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-523-94) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-523-11) 20 blister pack2022-03-030000-00-00NoNoCurrent