Posaconazole

Product NDC: 50268-683
11-digit product format: 502680683
Labeler code: 50268
Product ID: 50268-683_2b4c1730-ff8e-04ea-e063-6394a90a136b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Posaconazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: AvPAK
Application: ANDA212500
Marketing category: ANDA
Marketing start: 2022-05-09
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
Ingredient	Strength
POSACONAZOLE	100 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6TK1G07BHZ
Rxcui	1482908

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc1eab98-5691-4d9a-82e4-7e2823a44fa6	Product name	9	20251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-683-11	Posaconazole	1 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	1		2
50268-683-12	Posaconazole	20 in 1 BOX	TABLET, DELAYED RELEASE	20		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-683-11	EA - Each	50268-683	f1ed2191-fa5c-4224-b89c-97c1303d057b	1	2022-06-06
50268-683-12	EA - Each	50268-683	c40e7838-d528-426a-9b0b-c41f22c1c07b	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-683	POSACONAZOLE TABLET, DELAYED RELEASE [AVPAK]	2	Current NDC, Legacy NDC, 2 package rows	20250112_de95df83-a495-1900-e053-2995a90abf24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	de95df83-a495-1900-e053-2995a90abf24	2
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	de95df83-a495-1900-e053-2995a90abf24	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-683-11	50268068311	1 in 1 BLISTER PACK						Historical
50268-683-12	50268068312	20 BLISTER PACK in 1 BOX (50268-683-12) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-683-11)	20 blister pack	2022-05-09	0000-00-00	No	No	Current