NOXAFIL
- Product NDC
- 0085-2224
- 11-digit product format
- 000852224
- Labeler code
- 0085
- Product ID
- 0085-2224_56740f7d-3b29-4786-b5c7-eea6c0f14400
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- posaconazole
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA214770
- Marketing category
- NDA
- Marketing start
- 2021-06-08
- Substance
- POSACONAZOLE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214770-001 | NOXAFIL POWDERMIX KIT | POSACONAZOLE | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N214770-001 | I-984 | 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.
| 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 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD | 2021-05-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD | 2021-05-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD | 2021-05-31 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD | 2021-05-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD | 2021-05-31 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD | 2021-05-31 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD | 2021-05-31 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214770-001 | NOXAFIL POWDERMIX KIT | 300MG | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2021-05-31 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214770-001 | NP | 2024-05-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214770-001 | NP | 2024-05-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214770-001 | NP | 2024-05-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214770-001 | NP | 2024-05-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N214770-001 | NP | 2024-05-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214770-001 | NP | 2024-05-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214770-001 | NP | 2024-05-31 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214770-001 | NP | 2024-05-31 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N214770-001 | NP | 2024-05-31 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N214770-001 | NP | 2024-05-31 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N214770-001 | NP | 2024-05-31 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N214770-001 | NP | 2024-05-31 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N214770-001 | NP | 2024-05-31 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N214770-001 | NP | 2024-05-31 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214770-001 | NP | 2024-05-31 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N214770-001 | NP | 2024-05-31 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N214770-001 | NP | 2024-05-31 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N214770-001 | NP | 2024-05-31 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N214770-001 | NP | 2024-05-31 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N214770-001 | NP | 2024-05-31 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N214770-001 | NP | 2024-05-31 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N214770-001 | NP | 2024-05-31 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N214770-001 | NP | 2024-05-31 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N214770-001 | NP | 2024-05-31 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N214770-001 | NP | 2024-05-31 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N214770-001 | NP | 2024-05-31 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N214770-001 | NP | 2024-05-31 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214770-001 | I-984 | 2029-01-27 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NOXAFIL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POSACONAZOLE | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6TK1G07BHZ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| 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#
| Identifier | FDA.report destination |
|---|---|
| b073b082-7b57-4423-8c06-4fd4263d6f84 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0085-2224-01 | NOXAFIL | 1 in 1 PACKET | POWDER, FOR SUSPENSION | 1 | 56 | |
| 0085-2224-02 | NOXAFIL | 8 in 1 CARTON | POWDER, FOR SUSPENSION | 8 | 56 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0085-2224-01 | EA - Each | 0085-2224 | 99727b39-3c1c-4015-b7d0-69f0c32b3968 | 1 | 2022-12-07 |
| 0085-2224-02 | EA - Each | 0085-2224 | 6d5e4e2a-9565-4233-87bc-f2e459f8a155 | 1 | 2022-12-07 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0085-2224 | NOXAFIL (POSACONAZOLE) SUSPENSION NOXAFIL (POSACONAZOLE) TABLET, COATED NOXAFIL (POSACONAZOLE) SOLUTION NOXAFIL (POSACONAZOLE) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC] | 52 | Current NDC, Legacy NDC, 2 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NOXAFIL | POSACONAZOLE | Merck Sharp & Dohme LLC | b073b082-7b57-4423-8c06-4fd4263d6f84 | 2026-02-13 | Warnings, Adverse reactions | 214770 NDA214770 0085-2224 |
DailyMed RxNorm Mappings#
| 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0085-2224-01 | 00085222401 | 1 in 1 PACKET | Historical | |||||
| 0085-2224-02 | 00085222402 | 8 PACKET in 1 CARTON (0085-2224-02) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0085-2224-01) | 8 packet | 2021-06-08 | 0000-00-00 | No | No | Current |