POSACONAZOLE

Product NDC
0904-7149
11-digit product format
009047149
Labeler code
0904
Product ID
0904-7149_4edb3354-581c-4395-8a22-adc84d55c494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POSACONAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA213454
Marketing category
ANDA
Marketing start
2021-02-03
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
0904-7149-04POSACONAZOLE30 in 1 CARTONTABLET, DELAYED RELEASE307
0904-7149-04POSACONAZOLE1 in 1 BLISTER PACKTABLET, DELAYED RELEASE17
0904-7149-10POSACONAZOLE20 in 1 CARTONTABLET, DELAYED RELEASE207
0904-7149-10POSACONAZOLE1 in 1 BLISTER PACKTABLET, DELAYED RELEASE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7149-04EA - Each0904-71491d231672-627f-4abc-b15c-704aa22b3c7412022-01-06
0904-7149-10EA - Each0904-7149c4fcbad5-773b-4b8c-a792-04291c90a7ca12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7149POSACONAZOLE TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 4 package rows20250510_8e1e69b8-cf41-47cc-a3ec-1baee55f099a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSN8e1e69b8-cf41-47cc-a3ec-1baee55f099a7
1482908posaconazole 100 MG Delayed Release Oral TabletSCD8e1e69b8-cf41-47cc-a3ec-1baee55f099a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7149-040090471490430 BLISTER PACK in 1 CARTON (0904-7149-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK30 blister pack2021-02-030000-00-00NoNoCurrent
0904-7149-100090471491020 BLISTER PACK in 1 CARTON (0904-7149-10) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK20 blister pack2021-02-030000-00-00NoNoCurrent