Active ingredient
Tigecycline
8 finished FDA listings contain Tigecycline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TIGECYCLINE
- Dosage forms
- Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous, Parenteral
- Manufacturers / labelers
- 6
- Strengths listed
- 50 mg/1 · 50 mg/10ml · 50 mg/5ml
- Brand names in FDA listings
- Tygacil
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 384455
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 |
|---|---|---|---|
| NDA 021821 | PF PRISM CV | 2005-06-15 | 2 |
| ANDA 091620 | SANDOZ | 2015-05-27 | 1 |
| NDA 211158 | AMNEAL | 2018-08-02 | 1 |
| ANDA 204439 | APOTEX | 2018-12-21 | 1 |
| ANDA 206335 | EUGIA PHARMA | 2019-06-11 | 1 |
| ANDA 214020 | MEITHEAL | 2021-05-13 | 2 |
Official labeling on DailyMed
- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] · version 21 · 2026-07-27
- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 1 · 2026-04-02
- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP] · version 12 · 2026-01-09
- TYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] · version 50 · 2025-11-19
- TYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] · version 15 · 2025-11-19
- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 5 · 2025-09-05
- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] · version 8 · 2025-04-30
- TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] · version 19 · 2025-04-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.