Active ingredient
Daptomycin
53 finished FDA listings contain Daptomycin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DAPTOMYCIN
- Dosage forms
- Injection, Powder, Lyophilized, For Solution, Injection, Powder, Lyophilized, For Suspension, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 27
- Strengths listed
- 1000 mg/100ml · 350 mg/50ml · 350 mg/7ml · 50 mg/ml · 500 mg/1 · 500 mg/10ml · 500 mg/20ml · 500 mg/50ml · 700 mg/100ml
- Brand names in FDA listings
- Dapzura Rt
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 22299
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 |
|---|---|---|---|
| ANDA 206005 | XELLIA PHARMS APS | 2016-06-15 | 5 |
| NDA 208385 | SAGENT PHARMS INC | 2017-09-12 | 2 |
| NDA 209949 | HIKMA | 2017-10-20 | 3 |
| ANDA 206077 | FRESENIUS KABI USA | 2018-04-11 | 2 |
| ANDA 205037 | MYLAN LABS LTD | 2018-06-05 | 1 |
| ANDA 208375 | DR REDDYS | 2019-05-01 | 2 |
| ANDA 211961 | ACCORD HLTHCARE | 2019-06-24 | 1 |
| ANDA 212513 | BE PHARMS | 2019-06-26 | 1 |
| ANDA 212667 | ACCORD HLTHCARE | 2019-07-12 | 1 |
| ANDA 207104 | SAGENT PHARMS INC | 2019-11-15 | 1 |
| ANDA 213425 | BE PHARMS | 2020-08-20 | 1 |
| ANDA 211403 | DR REDDYS | 2020-08-31 | 1 |
| NDA 210282 | HOSPIRA | 2021-06-21 | 2 |
| ANDA 213786 | MEITHEAL | 2021-06-29 | 2 |
| ANDA 213623 | MEITHEAL | 2021-06-29 | 3 |
| ANDA 215316 | QILU PHARM HAINAN | 2021-08-24 | 2 |
| ANDA 213171 | EUGIA PHARMA | 2021-09-02 | 1 |
| NDA 213645 | BAXTER HLTHCARE CORP | 2022-01-25 | 5 |
| ANDA 215890 | HAINAN POLY PHARM | 2022-08-18 | 3 |
| ANDA 216413 | ASPIRO | 2022-09-23 | 3 |
| ANDA 216445 | ASPIRO | 2022-12-23 | 2 |
| NDA 217415 | HIKMA | 2023-01-30 | 5 |
| ANDA 213966 | MYLAN | 2023-08-07 | 1 |
| ANDA 217215 | BIOCON PHARMA | 2024-08-29 | 1 |
| NDA 217630 | MAIA PHARMS INC | 2024-11-21 | 2 |
Official labeling on DailyMed
- DAPTOMYCIN (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASPIRO PHARMA LIMITED] · version 2 · 2026-08-27
- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] · version 4 · 2026-08-17
- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] · version 16 · 2026-07-27
- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] · version 22 · 2026-07-24
- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOCON PHARMA INC.] · version 4 · 2026-07-21
- DAPZURA RT (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 7 · 2026-05-21
- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] · version 6 · 2026-05-12
- DAPTOMYCIN (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RXLLC] · version 2 · 2026-04-27
- DAPTOMYCIN (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.] · version 4 · 2026-04-27
- DAPTOMYCIN (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.] · version 4 · 2026-04-14
- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.] · version 2 · 2026-04-10
- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2026-03-24
Showing the 12 most recent of 47 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.