FDA.reportPublic FDA data

AFREZZA

Product NDC
47918-898
11-digit product format
479180898
Labeler code
47918
Product ID
47918-898_49f26445-3b5b-9c07-e063-6294a90a21a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INSULIN HUMAN
Dosage form
KIT
Route
RESPIRATORY (INHALATION)
Labeler
Mannkind Corporation
Application
BLA022472
Marketing category
BLA
Marketing start
2018-12-04
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Y17CTI5SRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1543202Internal RxNorm lookup
1543207Internal RxNorm lookup
1544488Internal RxNorm lookup
1544490Internal RxNorm lookup
1654910Internal RxNorm lookup
1654912Internal RxNorm lookup
1798387Internal RxNorm lookup
1798388Internal RxNorm lookup
1862101Internal RxNorm lookup
1862102Internal RxNorm lookup
2100028Internal RxNorm lookup
2100029Internal RxNorm lookup
2715452Internal RxNorm lookup
2715453Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29f4637b-e204-425b-b89c-7238008d8c10Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47918-898-18AFREZZA1 in 1 CARTONKIT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47918-898-18EA - Each47918-8988f57a201-5e32-4df2-b911-069ee6c3162812019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47918-898AFREZZA (INSULIN HUMAN) POWDER, METERED AFREZZA (INSULIN HUMAN) KIT [MANNKIND CORPORATION]14Current NDC, Legacy NDC, 1 package rows20240229_29f4637b-e204-425b-b89c-7238008d8c10.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
AFREZZAINSULIN HUMANMannkind Corporation29f4637b-e204-425b-b89c-7238008d8c102026-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA022472
ndc (product): 47918-898

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022472Afrezzainsulin human351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2715453{15 (insulin, regular, human 4 UNT Inhalation Powder [Afrezza]) / 15 (insulin, regular, human 8 UNT Inhalation Powder [Afrezza]) } Pack [Afrezza Sample Pack - 15 (4 UNT), 15 (8 UNT)]BPCK29f4637b-e204-425b-b89c-7238008d8c1016
1862102{60 (insulin, regular, human 12 UNT Inhalation Powder [Afrezza]) / 60 (insulin, regular, human 4 UNT Inhalation Powder [Afrezza]) / 60 (insulin, regular, human 8 UNT Inhalation Powder [Afrezza]) } Pack [Afrezza 180 Titration Pack- 60 (4 UNT), 60 (8 UNT), 60 (12 UNT)]BPCK29f4637b-e204-425b-b89c-7238008d8c1016
2100029{90 (insulin, regular, human 12 UNT Inhalation Powder [Afrezza]) / 90 (insulin, regular, human 8 UNT Inhalation Powder [Afrezza]) } Pack [Afrezza 180 - 90 (8 UNT), 90 (12 UNT)]BPCK29f4637b-e204-425b-b89c-7238008d8c1016
1798388{90 (insulin, regular, human 4 UNT Inhalation Powder [Afrezza]) / 90 (insulin, regular, human 8 UNT Inhalation Powder [Afrezza]) } Pack [Afrezza Titration Pack]BPCK29f4637b-e204-425b-b89c-7238008d8c1016
2715452{15 (insulin, regular, human 4 UNT Inhalation Powder) / 15 (insulin, regular, human 8 UNT Inhalation Powder) } PackGPCK29f4637b-e204-425b-b89c-7238008d8c1016
1862101{60 (insulin, regular, human 12 UNT Inhalation Powder) / 60 (insulin, regular, human 4 UNT Inhalation Powder) / 60 (insulin, regular, human 8 UNT Inhalation Powder) } PackGPCK29f4637b-e204-425b-b89c-7238008d8c1016
2100028{90 (insulin, regular, human 12 UNT Inhalation Powder) / 90 (insulin, regular, human 8 UNT Inhalation Powder) } PackGPCK29f4637b-e204-425b-b89c-7238008d8c1016
1798387{90 (insulin, regular, human 4 UNT Inhalation Powder) / 90 (insulin, regular, human 8 UNT Inhalation Powder) } PackGPCK29f4637b-e204-425b-b89c-7238008d8c1016
1654912afrezza 12 UNT Inhalation PowderPSN29f4637b-e204-425b-b89c-7238008d8c1016
2100029afrezza 180 Inhalation Cartridge Pack - 90 (8 UNT), 90 (12 UNT)PSN29f4637b-e204-425b-b89c-7238008d8c1016
1862102afrezza 180 Inhalation Cartridge Titration Pack - 60 (4 UNT), 60 (8 UNT), 60 (12 UNT)PSN29f4637b-e204-425b-b89c-7238008d8c1016
1798388afrezza 180 Inhalation Cartridge Titration Pack - 90 (4 UNT), 90 (8 UNT)PSN29f4637b-e204-425b-b89c-7238008d8c1016
2715453afrezza 30 Inhalation Cartridge Sample Pack - 15 (4 UNT), 15 (8 UNT)PSN29f4637b-e204-425b-b89c-7238008d8c1016
1543207afrezza 4 UNT Inhalation PowderPSN29f4637b-e204-425b-b89c-7238008d8c1016
1544490afrezza 8 UNT Inhalation PowderPSN29f4637b-e204-425b-b89c-7238008d8c1016
2715452insulin, regular, human 30 Inhalation Cartridge Sample Pack - 15 (4 UNT), 15 (8 UNT)PSN29f4637b-e204-425b-b89c-7238008d8c1016
1654910regular insulin, human 12 UNT Inhalation Powder CartridgePSN29f4637b-e204-425b-b89c-7238008d8c1016
2100028regular insulin, human 180 Inhalation Cartridge Pack - 90 (8 UNT), 90 (12 UNT)PSN29f4637b-e204-425b-b89c-7238008d8c1016
1862101regular insulin, human 180 Inhalation Powder Pack - 60 (4 UNT), 60 (8 UNT), 60 (12 UNT)PSN29f4637b-e204-425b-b89c-7238008d8c1016
1798387regular insulin, human 180 Inhalation Powder Titration Pack - 90 (4 UNT), 90 (8 UNT)PSN29f4637b-e204-425b-b89c-7238008d8c1016
1543202regular insulin, human 4 UNT Inhalation Powder CartridgePSN29f4637b-e204-425b-b89c-7238008d8c1016
1544488regular insulin, human 8 UNT Inhalation Powder CartridgePSN29f4637b-e204-425b-b89c-7238008d8c1016
1654912insulin, regular, human 12 UNT Inhalation Powder [Afrezza]SBD29f4637b-e204-425b-b89c-7238008d8c1016
1543207insulin, regular, human 4 UNT Inhalation Powder [Afrezza]SBD29f4637b-e204-425b-b89c-7238008d8c1016
1544490insulin, regular, human 8 UNT Inhalation Powder [Afrezza]SBD29f4637b-e204-425b-b89c-7238008d8c1016
1654910insulin, regular, human 12 UNT Inhalation PowderSCD29f4637b-e204-425b-b89c-7238008d8c1016
1543202insulin, regular, human 4 UNT Inhalation PowderSCD29f4637b-e204-425b-b89c-7238008d8c1016
1544488insulin, regular, human 8 UNT Inhalation PowderSCD29f4637b-e204-425b-b89c-7238008d8c1016
1654912Afrezza 12 UNT Inhalation PowderSY29f4637b-e204-425b-b89c-7238008d8c1016
2100029afrezza 180 Cartridge Pack - 90 (8 UNT), 90 (12 UNT)SY29f4637b-e204-425b-b89c-7238008d8c1016
1862102Afrezza 180 Inhalation Cartridge Titration Pack - 60 (4 UNT), 60 (8 UNT), 60 (12 UNT)SY29f4637b-e204-425b-b89c-7238008d8c1016
1543207Afrezza 4 UNT Inhalation PowderSY29f4637b-e204-425b-b89c-7238008d8c1016
1544490Afrezza 8 UNT Inhalation PowderSY29f4637b-e204-425b-b89c-7238008d8c1016
2715453Afrezza Sample Pack - 15 (4 UNT), 15 (8 UNT)SY29f4637b-e204-425b-b89c-7238008d8c1016
1798388Afrezza Titration Pack- 90 (4 UNT), 90 (8 UNT)SY29f4637b-e204-425b-b89c-7238008d8c1016
2715452insulin, regular, human 30 Inhalation Cartridge Sample Pack - 15 (4 UNT), 15 (8 UNT)SY29f4637b-e204-425b-b89c-7238008d8c1016
1654910regular insulin, human 12 UNT Inhalation Powder CartridgeSY29f4637b-e204-425b-b89c-7238008d8c1016
1862101regular insulin, human 180 Inhalation Powder Pack - 60 (4 UNT), 60 (8 UNT), 60 (12 UNT)SY29f4637b-e204-425b-b89c-7238008d8c1016
1543202regular insulin, human 4 UNT Inhalation Powder CartridgeSY29f4637b-e204-425b-b89c-7238008d8c1016
1544488regular insulin, human 8 UNT Inhalation Powder CartridgeSY29f4637b-e204-425b-b89c-7238008d8c1016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47918-898-18479180898181 KIT in 1 CARTON (47918-898-18) * 3 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 3 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE1 kit2018-12-040000-00-00NoNoCurrent