NOXAFIL

Product NDC
0085-4331
11-digit product format
000854331
Labeler code
0085
Product ID
0085-4331_56740f7d-3b29-4786-b5c7-eea6c0f14400
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
posaconazole
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
NDA205596
Marketing category
NDA
Marketing start
2014-03-13
Substance
POSACONAZOLE
Active strength
18 mg/mL
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205596-001NOXAFILPOSACONAZOLE300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD2014-03-13

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205596-001101179512029-03-13Drug product2018-12-06
N205596-00184100772029-03-13Drug product2014-04-08
N205596-00197508222029-03-13Drug product2017-11-28
N205596-00193582972031-06-24U-3160Drug product2016-06-23
N205596-00193582972031-06-24U-3171Drug product2016-06-23
N205596-00193582972031-06-24U-4415Drug product2016-06-23
N205596-00193582972031-06-24U-4416Drug product2016-06-23
N205596-00190237902031-07-04U-1698Drug product2015-05-29
N205596-00190237902031-07-04U-3160Drug product2015-05-29
N205596-00190237902031-07-04U-3171Drug product2015-05-29
N205596-00190237902031-07-04U-4415Drug product2015-05-29
N205596-00190237902031-07-04U-4416Drug product2015-05-29
N205596-00194935822033-02-27Drug product2016-12-15

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N205596-001ODE-3552028-06-17
N205596-001NPP2029-01-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD2014-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-133f01610625f2…
2019-09-15 20:21 UTC2019-09N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-03-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N205596-001NOXAFIL300MG/16.7ML (18MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2014-03-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205596-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205596-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205596-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205596-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205596-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205596-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205596-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205596-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205596-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205596-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205596-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205596-001AP15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205596-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205596-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205596-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205596-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205596-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205596-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205596-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N205596-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N205596-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205596-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205596-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205596-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N205596-001AP1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 9 · 353 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205596-001101179512029-03-13Drug product2018-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205596-00184100772029-03-13Drug product2014-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205596-00197508222029-03-13Drug product2017-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205596-00193582972031-06-24U-3171Drug product2016-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205596-00193582972031-06-24U-3160Drug product2016-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205596-00190237902031-07-04U-3171Drug product2015-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205596-00190237902031-07-04U-1698Drug product2015-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205596-00190237902031-07-04U-3160Drug product2015-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205596-00194935822033-02-27Drug product2016-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-001101179512029-03-13Drug product2018-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-00184100772029-03-13Drug product2014-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-00197508222029-03-13Drug product2017-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-00193582972031-06-24U-3171Drug product2016-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-00193582972031-06-24U-3160Drug product2016-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-00190237902031-07-04U-3171Drug product2015-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-00190237902031-07-04U-1698Drug product2015-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-00190237902031-07-04U-3160Drug product2015-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-00194935822033-02-27Drug product2016-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N205596-001101179512029-03-13Drug product2018-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205596-00184100772029-03-13Drug product2014-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205596-00197508222029-03-13Drug product2017-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205596-00193582972031-06-24U-3171Drug product2016-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205596-00193582972031-06-24U-3160Drug product2016-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205596-00190237902031-07-04U-3171Drug product2015-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205596-00190237902031-07-04U-1698Drug product2015-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205596-00190237902031-07-04U-3160Drug product2015-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205596-00194935822033-02-27Drug product2016-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-001101179512029-03-13Drug product2018-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-00184100772029-03-13Drug product2014-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-00197508222029-03-13Drug product2017-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-00193582972031-06-24U-3171Drug product2016-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-00193582972031-06-24U-3160Drug product2016-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-00190237902031-07-04U-3171Drug product2015-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-00190237902031-07-04U-1698Drug product2015-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-00190237902031-07-04U-3160Drug product2015-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-00194935822033-02-27Drug product2016-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205596-001101179512029-03-13Drug product2018-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205596-00184100772029-03-13Drug product2014-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205596-00197508222029-03-13Drug product2017-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205596-00193582972031-06-24U-3171Drug product2016-06-23b8a1b40f171c…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N205596-001ODE-3552028-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205596-001ODE-3552028-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N205596-001ODE-3552028-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205596-001ODE-3552028-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205596-001ODE-3552028-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205596-001NPP2024-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205596-001I-8812024-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205596-001ODE-3552028-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205596-001NPP2024-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205596-001I-8812024-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205596-001ODE-3552028-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205596-001NPP2024-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205596-001I-8812024-06-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205596-001ODE-3552028-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205596-001NPP2024-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205596-001I-8812024-06-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205596-001ODE-3552028-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205596-001NPP2024-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N205596-001I-8812024-06-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N205596-001ODE-3552028-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205596-001NPP2024-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205596-001I-8812024-06-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205596-001ODE-3552028-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205596-001NPP2024-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205596-001I-8812024-06-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205596-001ODE-3552028-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205596-001NPP2024-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205596-001I-8812024-06-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205596-001ODE-3552028-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205596-001NPP2024-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205596-001I-8812024-06-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205596-001ODE-3552028-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205596-001NPP2024-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205596-001I-8812024-06-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205596-001ODE-3552028-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205596-001NPP2024-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205596-001I-8812024-06-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205596-001ODE-3552028-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205596-001NPP2024-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205596-001I-8812024-06-174b0b4de00fa7…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POSACONAZOLE18 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6TK1G07BHZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
665019Internal RxNorm lookup
665022Internal RxNorm lookup
1482908Internal RxNorm lookup
1482912Internal RxNorm lookup
1492043Internal RxNorm lookup
1492047Internal RxNorm lookup
2558603Internal RxNorm lookup
2558607Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b073b082-7b57-4423-8c06-4fd4263d6f84Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc1eab98-5691-4d9a-82e4-7e2823a44fa6Product name920251124
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0085-4331-01NOXAFIL16.7 mL in 1 VIAL, GLASSSOLUTION16.756
0085-4331-01NOXAFIL1 in 1 CARTONSOLUTION156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-4331-01ML - Milliliter0085-43312f81192b-d1d3-47b1-bb93-6c08b8ece17c12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
posaconazoleACTIVE INGREDIENT6TK1G07BHZNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
posaconazoleACTIVE MOIETY6TK1G07BHZNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
anhydrous dextroseINACTIVE INGREDIENT5SL0G7R0OKNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
glycerinINACTIVE INGREDIENTPDC6A3C0OXNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
SULFOBUTYLETHER .BETA.-CYCLODEXTRININACTIVE INGREDIENT2PP9364507NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
TALCINACTIVE INGREDIENT7SEV7J4R1UNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
WATERINACTIVE INGREDIENT059QF0KO0RNOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22
xanthan gumINACTIVE INGREDIENTTTV12P4NEENOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION [MERCK SHARP & DOHME CORP.]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0085-4331NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION NOXAFIL (POSACONAZOLE) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC]52Current NDC, Legacy NDC, 2 package rows20241109_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NOXAFILPOSACONAZOLEMerck Sharp & Dohme LLCb073b082-7b57-4423-8c06-4fd4263d6f842026-02-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 205596
application number: NDA205596
ndc (product): 0085-4331

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482912Noxafil 100 MG Delayed Release Oral TabletPSNb073b082-7b57-4423-8c06-4fd4263d6f8456
665022NOXAFIL 200 MG in 5 mL Oral SuspensionPSNb073b082-7b57-4423-8c06-4fd4263d6f8456
1492047NOXAFIL 300 MG in 16.7 ML InjectionPSNb073b082-7b57-4423-8c06-4fd4263d6f8456
2558607Noxafil PowderMix 300 MG Powder for Oral SuspensionPSNb073b082-7b57-4423-8c06-4fd4263d6f8456
1482908posaconazole 100 MG Delayed Release Oral TabletPSNb073b082-7b57-4423-8c06-4fd4263d6f8456
665019posaconazole 200 MG in 5 mL Oral SuspensionPSNb073b082-7b57-4423-8c06-4fd4263d6f8456
1492043posaconazole 300 MG in 16.7 ML InjectionPSNb073b082-7b57-4423-8c06-4fd4263d6f8456
2558603posaconazole 300 MG Powder for Oral SuspensionPSNb073b082-7b57-4423-8c06-4fd4263d6f8456
149204716.7 ML posaconazole 18 MG/ML Injection [Noxafil]SBDb073b082-7b57-4423-8c06-4fd4263d6f8456
1482912posaconazole 100 MG Delayed Release Oral Tablet [Noxafil]SBDb073b082-7b57-4423-8c06-4fd4263d6f8456
2558607posaconazole 300 MG Powder for Oral Suspension [Noxafil]SBDb073b082-7b57-4423-8c06-4fd4263d6f8456
665022posaconazole 40 MG/ML Oral Suspension [Noxafil]SBDb073b082-7b57-4423-8c06-4fd4263d6f8456
149204316.7 ML posaconazole 18 MG/ML InjectionSCDb073b082-7b57-4423-8c06-4fd4263d6f8456
1482908posaconazole 100 MG Delayed Release Oral TabletSCDb073b082-7b57-4423-8c06-4fd4263d6f8456
2558603posaconazole 300 MG Powder for Oral SuspensionSCDb073b082-7b57-4423-8c06-4fd4263d6f8456
665019posaconazole 40 MG/ML Oral SuspensionSCDb073b082-7b57-4423-8c06-4fd4263d6f8456
1482912Noxafil 100 MG Delayed Release Oral TabletSYb073b082-7b57-4423-8c06-4fd4263d6f8456
665022Noxafil 200 MG per 5 ML Oral SuspensionSYb073b082-7b57-4423-8c06-4fd4263d6f8456
1492047Noxafil 300 MG per 16.7 ML InjectionSYb073b082-7b57-4423-8c06-4fd4263d6f8456
2558607Noxafil 300 MG Powder for Oral SuspensionSYb073b082-7b57-4423-8c06-4fd4263d6f8456
665022Noxafil 40 MG/ML Oral SuspensionSYb073b082-7b57-4423-8c06-4fd4263d6f8456
665019posaconazole 200 MG per 5 ML Oral SuspensionSYb073b082-7b57-4423-8c06-4fd4263d6f8456
1492043posaconazole 300 MG per 16.7 ML InjectionSYb073b082-7b57-4423-8c06-4fd4263d6f8456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0085-4331-01000854331011 VIAL, GLASS in 1 CARTON (0085-4331-01) / 16.7 mL in 1 VIAL, GLASS2014-03-130000-00-00NoNoCurrent