Active ingredient
Insulin, Regular, Human
19 finished FDA listings contain Insulin, Regular, Human as their only active ingredient; 11 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- INSULIN HUMAN
- Dosage forms
- Injection, Solution, Injection, Suspension, Powder, Metered
- Routes
- Intravenous, Parenteral, Respiratory (Inhalation), Subcutaneous
- Manufacturers / labelers
- 6
- Strengths listed
- 1 [iu]/ml · 100 [iu]/ml · 12 [arb'u]/1 · 4 [arb'u]/1 · 500 [iu]/ml · 8 [arb'u]/1
- Brand names in FDA listings
- Afrezza, Humulin 70/30, Humulin 70/30 Kwikpen, Humulin N, Humulin R, Humulin R U-500 Kwikpen, Myxredlin, Novolin 70/30, Novolin N, Novolin R
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 253182
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 018781 | LILLY | 1982-10-28 | 2 |
| BLA 018780 | LILLY | 1982-10-28 | 4 |
| BLA 019717 | LILLY | 1989-04-25 | 2 |
| BLA 019991 | NOVO NORDISK INC | 1991-06-25 | 3 |
| BLA 019938 | NOVO NORDISK INC | 1991-06-25 | 2 |
| BLA 019959 | NOVO NORDISK INC | 1991-07-01 | 2 |
| BLA 022472 | MANNKIND | 2014-06-27 | 3 |
| BLA 208157 | BAXTER HLTHCARE CORP | 2019-06-20 | 1 |
Official labeling on DailyMed
- HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY] · version 35 · 2026-09-07
- HUMULIN 70/30 (INSULIN HUMAN) INJECTION, SUSPENSION HUMULIN 70/30 KWIKPEN (INSULIN HUMAN) INJECTION, SUSPENSION [ELI LILLY AND COMPANY] · version 50 · 2026-09-02
- HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION HUMULIN R U-500 KWIKPEN (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY] · version 41 · 2026-09-02
- MYXREDLIN (INSULIN HUMAN) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 12 · 2026-07-24
- AFREZZA (INSULIN HUMAN) POWDER, METERED AFREZZA (INSULIN HUMAN) POWDER, METERED AFREZZA (INSULIN HUMAN) KIT [MANNKIND CORPORATION] · version 17 · 2026-06-26
- HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [ELI LILLY AND COMPANY] · version 50 · 2025-12-31
- HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 25 · 2024-01-03
- NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] · version 14 · 2023-08-01
- NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] · version 19 · 2022-12-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.