POSACONAZOLE

Product NDC: 16714-156
11-digit product format: 167140156
Labeler code: 16714
Product ID: 16714-156_c4d3b57f-6031-43e4-93db-143b789151c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Posaconazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA212411
Marketing category: ANDA
Marketing start: 2021-05-18
Marketing end: 0000-00-00
Substance: POSACONAZOLE
Active strength: 100 mg/1
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	16714-156		D	Discontinued by firm		2026-08-11
excluded package	package	16714-156	16714-156-01	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-156-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16714-156-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A212411-001	POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2019-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212411-001	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	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212411-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-08-21	`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	A212411-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212411-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212411-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212411-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212411-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212411-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212411-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212411-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212411-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212411-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212411-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212411-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212411-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212411-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212411-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212411-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212411-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212411-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212411-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212411-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212411-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212411-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212411-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212411-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212411-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212411-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212411-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212411-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212411-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212411-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212411-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212411-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212411-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212411-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212411-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212411-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212411-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212411-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212411-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212411-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-156-01	EA - Each	16714-156	fe0d50f8-751d-47a6-9263-aa9011d32eea	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-156	POSACONAZOLE TABLET, DELAYED RELEASE [NORTHSTAR RXLLC]	6	Legacy NDC	20240725_889af4cc-6282-4ca3-9027-dba9d3747e8c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POSACONAZOLE	POSACONAZOLE	ATLANTIC BIOLOGICALS CORP.	dfbc636f-d8a7-4232-a6b0-cda49caadc9b	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212411 application number: ANDA212411
Posaconazole	POSACONAZOLE	American Health Packaging	e809a31a-09da-46bf-bcaa-f34b7f3b54a3	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212411 application number: ANDA212411
POSACONAZOLE	POSACONAZOLE	Lannett Company Inc.	94a9b028-a2bc-4f41-884d-2d6c536881fc	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212411 application number: ANDA212411
POSACONAZOLE	POSACONAZOLE DELAYED-RELEASE	Chartwell RX, LLC	f2baa339-75ff-4c03-8334-a88648f701f7	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212411 application number: ANDA212411

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-156-01	16714015601	60 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-156-01)	2021-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POSACONAZOLE	NorthStar RxLLC \| Sinotherapeutics Inc. \| Haimen Pharma Inc.	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	6