POSACONAZOLE

Product NDC: 0527-2133
11-digit product format: 005272133
Labeler code: 0527
Product ID: 0527-2133_291b0655-036f-4073-a475-c33a411db178
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Posaconazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Lannett Company Inc.
Application: ANDA212411
Marketing category: ANDA
Marketing start: 2019-08-28
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
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…`

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
94a9b028-a2bc-4f41-884d-2d6c536881fc	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
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0527-2133-30	POSACONAZOLE	24 in 1 CARTON	TABLET, DELAYED RELEASE	24	15
0527-2133-35	POSACONAZOLE	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	15
0527-2133-43	POSACONAZOLE	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-2133-35	EA - Each	0527-2133	3c3702d4-5731-445a-a3d5-c222d8c5feaf	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-2133	POSACONAZOLE TABLET, DELAYED RELEASE [LANNETT COMPANY INC.]	15	Current NDC, Legacy NDC, 3 package rows	20250104_94a9b028-a2bc-4f41-884d-2d6c536881fc.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 ndc (product): 0527-2133
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	94a9b028-a2bc-4f41-884d-2d6c536881fc	15
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	94a9b028-a2bc-4f41-884d-2d6c536881fc	15
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	e809a31a-09da-46bf-bcaa-f34b7f3b54a3	6
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	e809a31a-09da-46bf-bcaa-f34b7f3b54a3	6
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	dfbc636f-d8a7-4232-a6b0-cda49caadc9b	4
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	dfbc636f-d8a7-4232-a6b0-cda49caadc9b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-2133-30	00527213330	24 TABLET, DELAYED RELEASE in 1 CARTON (0527-2133-30)	2021-01-31	0000-00-00	No	No	Current
0527-2133-35	00527213335	60 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-35)	2019-08-28	0000-00-00	No	No	Current
0527-2133-43	00527213343	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-43)	2019-08-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POSACONAZOLE	ATLANTIC BIOLOGICALS CORP.	2026-04-20	HUMAN PRESCRIPTION DRUG LABEL	4
Posaconazole	American Health Packaging	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	6
POSACONAZOLE	Lannett Company Inc. \| Sinotherapeutics Inc. \| Haimen Pharma Inc.	2024-12-03	HUMAN PRESCRIPTION DRUG LABEL	15