NOXAFIL

Product NDC: 0085-4324
11-digit product format: 000854324
Labeler code: 0085
Product ID: 0085-4324_56740f7d-3b29-4786-b5c7-eea6c0f14400
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: posaconazole
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Merck Sharp & Dohme LLC
Application: NDA205053
Marketing category: NDA
Marketing start: 2013-11-25
Substance: POSACONAZOLE
Active strength: 100 mg/1
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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N205053-001	NOXAFIL	POSACONAZOLE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25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 · 42 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
2026-08-18 06:07:40	2026-07	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`caaa826d4ba7…`
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UTC	2026-02	N205053-001	NOXAFIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2013-11-25	`011fe1cb6892…`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…`

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 · 89 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N205053-001	ODE-355	2028-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205053-001	NPP	2029-01-27	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: NOXAFIL
Listing expiration: 2027-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
665019	Internal RxNorm lookup
665022	Internal RxNorm lookup
1482908	Internal RxNorm lookup
1482912	Internal RxNorm lookup
1492043	Internal RxNorm lookup
1492047	Internal RxNorm lookup
2558603	Internal RxNorm lookup
2558607	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
b073b082-7b57-4423-8c06-4fd4263d6f84	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	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
0085-4324-02	NOXAFIL	60 in 1 BOTTLE	TABLET, COATED	60		56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0085-4324-02	EA - Each	0085-4324	9e6f92fe-7936-4813-a2a6-8bcdda088399	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
posaconazole	ACTIVE INGREDIENT	6TK1G07BHZ	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
posaconazole	ACTIVE MOIETY	6TK1G07BHZ	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
anhydrous dextrose	INACTIVE INGREDIENT	5SL0G7R0OK	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)	INACTIVE INGREDIENT	6N003M473W	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
SULFOBUTYLETHER .BETA.-CYCLODEXTRIN	INACTIVE INGREDIENT	2PP9364507	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
WATER	INACTIVE INGREDIENT	059QF0KO0R	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0085-4324	NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION NOXAFIL (POSACONAZOLE) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC]	52	Current NDC, Legacy NDC, 1 package rows	20241109_b073b082-7b57-4423-8c06-4fd4263d6f84.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 ndc (product): 0085-4324
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

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
1482912	Noxafil 100 MG Delayed Release Oral Tablet	PSN	b073b082-7b57-4423-8c06-4fd4263d6f84	56
665022	NOXAFIL 200 MG in 5 mL Oral Suspension	PSN	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1492047	NOXAFIL 300 MG in 16.7 ML Injection	PSN	b073b082-7b57-4423-8c06-4fd4263d6f84	56
2558607	Noxafil PowderMix 300 MG Powder for Oral Suspension	PSN	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	b073b082-7b57-4423-8c06-4fd4263d6f84	56
665019	posaconazole 200 MG in 5 mL Oral Suspension	PSN	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1492043	posaconazole 300 MG in 16.7 ML Injection	PSN	b073b082-7b57-4423-8c06-4fd4263d6f84	56
2558603	posaconazole 300 MG Powder for Oral Suspension	PSN	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1492047	16.7 ML posaconazole 18 MG/ML Injection [Noxafil]	SBD	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1482912	posaconazole 100 MG Delayed Release Oral Tablet [Noxafil]	SBD	b073b082-7b57-4423-8c06-4fd4263d6f84	56
2558607	posaconazole 300 MG Powder for Oral Suspension [Noxafil]	SBD	b073b082-7b57-4423-8c06-4fd4263d6f84	56
665022	posaconazole 40 MG/ML Oral Suspension [Noxafil]	SBD	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1492043	16.7 ML posaconazole 18 MG/ML Injection	SCD	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	b073b082-7b57-4423-8c06-4fd4263d6f84	56
2558603	posaconazole 300 MG Powder for Oral Suspension	SCD	b073b082-7b57-4423-8c06-4fd4263d6f84	56
665019	posaconazole 40 MG/ML Oral Suspension	SCD	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1482912	Noxafil 100 MG Delayed Release Oral Tablet	SY	b073b082-7b57-4423-8c06-4fd4263d6f84	56
665022	Noxafil 200 MG per 5 ML Oral Suspension	SY	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1492047	Noxafil 300 MG per 16.7 ML Injection	SY	b073b082-7b57-4423-8c06-4fd4263d6f84	56
2558607	Noxafil 300 MG Powder for Oral Suspension	SY	b073b082-7b57-4423-8c06-4fd4263d6f84	56
665022	Noxafil 40 MG/ML Oral Suspension	SY	b073b082-7b57-4423-8c06-4fd4263d6f84	56
665019	posaconazole 200 MG per 5 ML Oral Suspension	SY	b073b082-7b57-4423-8c06-4fd4263d6f84	56
1492043	posaconazole 300 MG per 16.7 ML Injection	SY	b073b082-7b57-4423-8c06-4fd4263d6f84	56

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0085-4324-02	00085432402	60 TABLET, COATED in 1 BOTTLE (0085-4324-02)	2013-11-25	0000-00-00	No	No	Current