Posaconazole

Product NDC: 72319-023
11-digit product format: 723190023
Labeler code: 72319
Product ID: 72319-023_3249c585-7620-444f-e063-6294a90ae5ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Posaconazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: i3 Pharmaceuticals, LLC
Application: ANDA216488
Marketing category: ANDA
Marketing start: 2023-09-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216488-001	POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A216488-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216488-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216488-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216488-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216488-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216488-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216488-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216488-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216488-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216488-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216488-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216488-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216488-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216488-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216488-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216488-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216488-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216488-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216488-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216488-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216488-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216488-001	AB	1	`a50c72e98297…`

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6TK1G07BHZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1482908	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d5300d14-219d-4e1e-bfac-b413c40d6e3a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc1eab98-5691-4d9a-82e4-7e2823a44fa6	Product name	9	20251124
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72319-023-02	Posaconazole	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72319-023	POSACONAZOLE TABLET, DELAYED RELEASE [I3 PHARMACEUTICALS, LLC]	4	Current NDC, 1 package rows	20250410_d5300d14-219d-4e1e-bfac-b413c40d6e3a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Posaconazole	POSACONAZOLE	Bryant Ranch Prepack	f15fc7d4-04ea-4be5-bfed-9a8bae74591c	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216488 application number: ANDA216488
Posaconazole	POSACONAZOLE	Bryant Ranch Prepack	42a53b61-be3b-4c69-a3df-d12401dbd0e4	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216488 application number: ANDA216488
Posaconazole	POSACONAZOLE	A2A Integrated Pharmaceuticals	4d14ceab-196e-4dc3-8b21-5c4629ada161	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216488 application number: ANDA216488
Posaconazole	POSACONAZOLE	i3 Pharmaceuticals, LLC	d5300d14-219d-4e1e-bfac-b413c40d6e3a	2024-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216488 application number: ANDA216488 ndc (product): 72319-023
Posaconazole	POSACONAZOLE	Bryant Ranch Prepack	d2daba09-f1c2-4764-a567-1291be4892b9	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216488 application number: ANDA216488

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6TK1G07BHZ	POSACONAZOLE	171228-49-2	POSACONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	d2daba09-f1c2-4764-a567-1291be4892b9	101
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	d2daba09-f1c2-4764-a567-1291be4892b9	101
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	42a53b61-be3b-4c69-a3df-d12401dbd0e4	100
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	f15fc7d4-04ea-4be5-bfed-9a8bae74591c	100
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	42a53b61-be3b-4c69-a3df-d12401dbd0e4	100
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	f15fc7d4-04ea-4be5-bfed-9a8bae74591c	100
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	d5300d14-219d-4e1e-bfac-b413c40d6e3a	4
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	d5300d14-219d-4e1e-bfac-b413c40d6e3a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72319-023-02	72319002302	60 TABLET, DELAYED RELEASE in 1 BOTTLE (72319-023-02)	2023-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Posaconazole	Bryant Ranch Prepack	2025-11-11	HUMAN PRESCRIPTION DRUG LABEL	100
Posaconazole	Bryant Ranch Prepack	2025-06-26	HUMAN PRESCRIPTION DRUG LABEL	100
Posaconazole	i3 Pharmaceuticals, LLC	2024-11-29	HUMAN PRESCRIPTION DRUG LABEL	4
Posaconazole	Bryant Ranch Prepack	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL	101