POSACONAZOLE

Product NDC: 63629-2236
11-digit product format: 636292236
Labeler code: 63629
Product ID: 63629-2236_97286b24-40cd-43d6-8c55-43eed6c3cb83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: posaconazole
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA205053
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-08-30
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
N205053-001	NOXAFIL	POSACONAZOLE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205053-001	ODE-355	2028-06-17
N205053-001	NPP	2029-01-27

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2013-11-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205053-001	NOXAFIL	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-11-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205053-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205053-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205053-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205053-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205053-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205053-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205053-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205053-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205053-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205053-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205053-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205053-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205053-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205053-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205053-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205053-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205053-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205053-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205053-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205053-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205053-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205053-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205053-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205053-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205053-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205053-001	5661151	2019-07-19	U-1454	Drug substance, Drug product	2013-12-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N205053-001	5661151	2019-07-19	U-1454	Drug substance, Drug product	2013-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205053-001	5661151	2019-07-19	U-1454	Drug substance, Drug product	2013-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205053-001	5661151	2019-07-19	U-1454	Drug substance, Drug product	2013-12-10	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205053-001	ODE-355	2028-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205053-001	ODE-355	2028-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205053-001	ODE-355	2028-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205053-001	ODE-355	2028-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205053-001	ODE-355	2028-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205053-001	NPP	2024-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205053-001	I-881	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205053-001	ODE-355	2028-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205053-001	NPP	2024-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205053-001	I-881	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205053-001	ODE-355	2028-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205053-001	NPP	2024-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205053-001	I-881	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205053-001	ODE-355	2028-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205053-001	NPP	2024-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205053-001	I-881	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205053-001	ODE-355	2028-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205053-001	NPP	2024-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205053-001	I-881	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205053-001	ODE-355	2028-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	NPP	2024-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	I-881	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205053-001	ODE-355	2028-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	NPP	2024-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	I-881	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205053-001	ODE-355	2028-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	NPP	2024-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	I-881	2024-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205053-001	ODE-355	2028-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205053-001	NPP	2024-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205053-001	I-881	2024-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205053-001	ODE-355	2028-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	NPP	2024-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	I-881	2024-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205053-001	ODE-355	2028-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205053-001	NPP	2024-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205053-001	I-881	2024-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205053-001	ODE-355	2028-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205053-001	NPP	2024-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205053-001	I-881	2024-06-17	`4b0b4de00fa7…`

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
e2b69c68-8696-4f81-8e2f-e4798116d055	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	Strength	SPL version
63629-2236-1	POSACONAZOLE	60 in 1 BOTTLE	TABLET, COATED	60		108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2236-1	EA - Each	63629-2236	2dfb4b35-ade5-4d96-b8e6-2b307a8edfdd	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2236	POSACONAZOLE TABLET, COATED [BRYANT RANCH PREPACK]	108	Current NDC, Legacy NDC, 1 package rows	20240912_e2b69c68-8696-4f81-8e2f-e4798116d055.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POSACONAZOLE	POSACONAZOLE	ENDO USA, Inc.	e031b632-8e57-4359-87bd-a5da02bdc55f	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205053 application number: NDA205053
NOXAFIL	POSACONAZOLE	Merck Sharp & Dohme LLC	b073b082-7b57-4423-8c06-4fd4263d6f84	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205053 application number: NDA205053
POSACONAZOLE	POSACONAZOLE	Bryant Ranch Prepack	e2b69c68-8696-4f81-8e2f-e4798116d055	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205053 application number: NDA205053 ndc (product): 63629-2236

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	e2b69c68-8696-4f81-8e2f-e4798116d055	108
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	e2b69c68-8696-4f81-8e2f-e4798116d055	108

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2236-1	63629223601	60 TABLET, COATED in 1 BOTTLE (63629-2236-1)	2024-09-05	0000-00-00	No	No	Current