FDA.reportPublic FDA data

AFREZZA

Product NDC
47918-891
11-digit product format
479180891
Labeler code
47918
Product ID
47918-891_49f26445-3b5b-9c07-e063-6294a90a21a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INSULIN HUMAN
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Mannkind Corporation
Application
BLA022472
Marketing category
BLA
Marketing start
2017-07-01
Substance
INSULIN HUMAN
Active strength
12 [arb'U]/1
Pharmacologic classes
Insulin [CS], Insulin [EPC]
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN HUMAN12 [arb'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui1543202, 1543207, 1544488, 1544490, 1654910, 1654912, 1798387, 1798388, 1862101, 1862102, 2100028, 2100029, 2715452, 2715453

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
47918-891-90AFREZZA2 in 1 POUCHPOWDER, METERED216
47918-891-90AFREZZA3 in 1 CARTONPOWDER, METERED316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47918-891-90EA - Each47918-8912ba7b51f-7806-4d3d-b125-20002ca9f0e712017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47918-891AFREZZA (INSULIN HUMAN) POWDER, METERED AFREZZA (INSULIN HUMAN) KIT [MANNKIND CORPORATION]14Current NDC, Legacy NDC, 2 package rows20240229_29f4637b-e204-425b-b89c-7238008d8c10.zip

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
47918-891-90479180891903 POUCH in 1 CARTON (47918-891-90) / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE3 pouch2017-07-010000-00-00NoNoCurrent