Prescription drug · BLA
Afrezza (Insulin human) NDC 47918-891
Insulin human 12 [arb'U]/1 · Powder, Metered · Respiratory (Inhalation) · Mannkind Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47918-891-90 | 4791808919047918089190 | 3 POUCH in 1 CARTON (47918-891-90) / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGEMarketed from Jul 1, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Afrezza
- Generic name (nonproprietary)
- insulin human
- Active ingredients
- Insulin human — 12 [arb'U]/1
- Dosage form
- Powder, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Mannkind CorporationNDC labeler code 47918
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 022472
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 47918-891_51ca8d95-025a-6342-e063-6294a90a94eeSPL ID 51ca8d95-025a-6342-e063-6294a90a94eeSPL set ID 29f4637b-e204-425b-b89c-7238008d8c10RxCUI 1543202, 1543207, 1544488, 1544490, 1654910, 1654912, 1798387, 1798388, 1862101, 1862102, 2100028, 2100029, 2715452, 2715453UNII 1Y17CTI5SR
- Pharmacologic class
- Insulin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N447918089190followed by a unit qualifier and the quantityPackage 47918-0891-90. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis (DKA) ( 1 ) Not recommended in patients who smoke or who have recently stopped smoking ( 1 ) Limitations of Use: AFREZZA is not recommended for the treatment of diabetic ketoacidosis (DKA) [see Warnings and Precautions ( 5.6 )] . The safety and effectiveness of AFREZZA in patients who smoke have not been establi…
Excerpt only. Read the full label for complete information.
About NDC 47918-891
- What is NDC 47918-891?
- 47918-891 is the product NDC for Afrezza (insulin human), Insulin human 12 [arb'U]/1 powder, metered, listed with the FDA by Mannkind Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Afrezza (Insulin human).
- What is the active ingredient?
- Insulin human.
- Who is the labeler?
- Mannkind Corporation, NDC labeler code 47918. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Afrezza?
- 6 other product NDCs are listed under this name. See all Afrezza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Afrezza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Afrezzainsulin human | — | KitRespiratory (Inhalation) | Mannkind Corporation | 47918-904 | 47918-0904-30 |
| Afrezzainsulin human | — | KitRespiratory (Inhalation) | Mannkind Corporation | 47918-898 | 47918-0898-18 |
| Afrezzainsulin human | Insulin human 8 [arb'U]/1 | Powder, MeteredRespiratory (Inhalation) | Mannkind Corporation | 47918-878 | 47918-0878-90 |
| Afrezzainsulin human | — | KitRespiratory (Inhalation) | Mannkind Corporation | 47918-902 | 47918-0902-18 |
| Afrezzainsulin human | — | KitRespiratory (Inhalation) | Mannkind Corporation | 47918-880 | 47918-0880-18 |
| Afrezzainsulin human | Insulin human 4 [arb'U]/1 | Powder, MeteredRespiratory (Inhalation) | Mannkind Corporation | 47918-874 | 47918-0874-90 |
Other NDCs under BLA 022472
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Afrezzainsulin human | Insulin human 4 [arb'U]/1 | Powder, MeteredRespiratory (Inhalation) | Mannkind Corporation | 47918-874 |
| Afrezzainsulin human | Insulin human 8 [arb'U]/1 | Powder, MeteredRespiratory (Inhalation) | Mannkind Corporation | 47918-878 |
| Afrezzainsulin human | — | KitRespiratory (Inhalation) | Mannkind Corporation | 47918-880 |
| Afrezzainsulin human | — | KitRespiratory (Inhalation) | Mannkind Corporation | 47918-898 |
| Afrezzainsulin human | — | KitRespiratory (Inhalation) | Mannkind Corporation | 47918-902 |
| Afrezzainsulin human | — | KitRespiratory (Inhalation) | Mannkind Corporation | 47918-904 |