FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POSACONAZOLE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6TK1G07BHZ
Rxcui665019, 665022, 1482908, 1482912, 1492043, 1492047, 2558603, 2558607

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
0085-2224-01NOXAFIL1 in 1 PACKETPOWDER, FOR SUSPENSION156
0085-2224-02NOXAFIL8 in 1 CARTONPOWDER, FOR SUSPENSION856

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-2224-01EA - Each0085-222499727b39-3c1c-4015-b7d0-69f0c32b396812022-12-07
0085-2224-02EA - Each0085-22246d5e4e2a-9565-4233-87bc-f2e459f8a15512022-12-07

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
0085-2224NOXAFIL (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

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0085-2224-01000852224011 in 1 PACKETHistorical
0085-2224-02000852224028 PACKET in 1 CARTON (0085-2224-02) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0085-2224-01) 8 packet2021-06-080000-00-00NoNoCurrent