afrezza

Generic: insulin human

Labeler: mannkind corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name afrezza
Generic Name insulin human
Labeler mannkind corporation
Dosage Form KIT
Routes
RESPIRATORY (INHALATION)
Manufacturer
Mannkind Corporation

Identifiers & Regulatory

Product NDC 47918-904
Product ID 47918-904_49f26445-3b5b-9c07-e063-6294a90a21a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA022472
Listing Expiration 2027-12-31
Marketing Start 2025-06-01

Pharmacologic Class

Established (EPC)
insulin [epc]
Chemical Structure
insulin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47918904
Hyphenated Format 47918-904

Supplemental Identifiers

RxCUI
1543202 1543207 1544488 1544490 1654910 1654912 1798387 1798388 1862101 1862102 2100028 2100029 2715452 2715453
UNII
1Y17CTI5SR
NUI
M0011417 N0000175944

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name afrezza (source: ndc)
Generic Name insulin human (source: ndc)
Application Number BLA022472 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 4 unit
  • 8 unit
  • 12 unit
  • 360 unit
  • 720 unit
  • 1080 unit
  • 1800 unit
  • 1440 unit
source: label
Packaging
  • 1 KIT in 1 CARTON (47918-904-30) * 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE
source: ndc

Packages (1)

47918-904-30 1 KIT in 1 CARTON (47918-904-30) * 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

AFREZZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "49f26445-3b5b-9c07-e063-6294a90a21a6", "openfda": {"nui": ["M0011417", "N0000175944"], "unii": ["1Y17CTI5SR"], "rxcui": ["1543202", "1543207", "1544488", "1544490", "1654910", "1654912", "1798387", "1798388", "1862101", "1862102", "2100028", "2100029", "2715452", "2715453"], "spl_set_id": ["29f4637b-e204-425b-b89c-7238008d8c10"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin [EPC]"], "manufacturer_name": ["Mannkind Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 KIT in 1 CARTON (47918-904-30)  *  15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE *  15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE", "package_ndc": "47918-904-30", "marketing_start_date": "20250601"}], "brand_name": "AFREZZA", "product_id": "47918-904_49f26445-3b5b-9c07-e063-6294a90a21a6", "dosage_form": "KIT", "product_ndc": "47918-904", "generic_name": "INSULIN HUMAN", "labeler_name": "Mannkind Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AFREZZA", "application_number": "BLA022472", "marketing_category": "BLA", "marketing_start_date": "20250601", "listing_expiration_date": "20271231"}