Active ingredient
Bupivacaine
116 finished FDA listings contain Bupivacaine as their only active ingredient; 30 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- BUPIVACAINE, BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE ANHYDROUS
- Dosage forms
- Injection, Injection, Solution, Injection, Suspension, Liposomal
- Routes
- Epidural, Infiltration, Intracaudal, Perineural, Retrobulbar, Subarachnoid
- Manufacturers / labelers
- 27
- Strengths listed
- 13.3 mg/ml · 150 mg/30ml · 2.5 mg/ml · 225 mg/30ml · 25 mg/10ml · 250 mg/50ml · 5 mg/ml · 50 mg/10ml · 7.5 mg/ml · 75 mg/30ml
- Brand names in FDA listings
- Bupivacaine Hcl, Bupivacaine Spinal, Bupivacine Hcl, Exparel, Marcaine, Marcaine Spinal, Marvona Suik, Marvona-25 Suik, Sensorcaine, Sensorcaine Mpf
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1815
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 016964 | HOSPIRA | 1972-10-03 | 11 |
| NDA 018304 | FRESENIUS KABI USA | 1981-12-30 | 10 |
| NDA 018692 | HOSPIRA | 1984-05-04 | 1 |
| ANDA 070553 | FRESENIUS KABI USA | 1986-05-21 | 3 |
| ANDA 070554 | FRESENIUS KABI USA | 1986-05-21 | 1 |
| ANDA 070552 | FRESENIUS KABI USA | 1986-05-21 | 2 |
| ANDA 070590 | HOSPIRA | 1987-02-17 | 4 |
| ANDA 070583 | HOSPIRA | 1987-02-17 | 6 |
| ANDA 070584 | HOSPIRA | 1987-02-17 | 4 |
| ANDA 070597 | HOSPIRA | 1987-03-03 | 3 |
| ANDA 070585 | HOSPIRA | 1987-03-03 | 1 |
| ANDA 071810 | HOSPIRA | 1987-12-11 | 1 |
| ANDA 091487 | ONESOURCE SPECIALTY | 2011-10-18 | 14 |
| ANDA 091503 | ONESOURCE SPECIALTY | 2011-10-18 | 4 |
| NDA 022496 | PACIRA PHARMS INC | 2011-10-28 | 2 |
| ANDA 203895 | EUGIA PHARMA | 2013-11-05 | 8 |
| ANDA 207183 | EUGIA PHARMA | 2016-05-13 | 7 |
| ANDA 209087 | B BRAUN MEDICAL | 2019-04-02 | 1 |
| ANDA 212822 | HUONS | 2019-12-30 | 2 |
| ANDA 205141 | HIKMA PHARMS | 2021-02-11 | 2 |
| ANDA 204842 | HIKMA PHARMS | 2021-02-11 | 7 |
| ANDA 216039 | MEITHEAL | 2023-06-23 | 4 |
| ANDA 217792 | SOMERSET | 2023-11-20 | 2 |
| ANDA 217821 | ASPIRO | 2024-03-27 | 9 |
| ANDA 214348 | HENGRUI PHARMA | 2024-07-01 | 2 |
| ANDA 220493 | ADAPTIS | 2026-04-22 | 3 |
Official labeling on DailyMed
- BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [FOSUN PHARMA USA INC.] · version 3 · 2026-07-31
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NORTHSTAR RXLLC] · version 3 · 2026-07-21
- MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 1 · 2026-07-13
- MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 2 · 2026-07-02
- MARCAINE SPINAL (BUPIVACAINE HYDROCHLORIDE IN DEXTROSE) INJECTION, SOLUTION [HOSPIRA, INC.] · version 27 · 2026-06-24
- BUPIVACAINE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 7 · 2026-06-23
- MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.] · version 38 · 2026-06-01
- BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] · version 17 · 2026-04-30
- BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SPORTPHARM LLC] · version 2 · 2026-04-27
- BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [ANTHEA PHARMA PRIVATE LIMITED] · version 5 · 2026-04-24
- BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] · version 21 · 2026-04-16
- BUPIVACAINE SPINAL (BUPIVACAINE HYDROCHLORIDE IN DEXTROSE) INJECTION, SOLUTION [HOSPIRA, INC.] · version 29 · 2026-04-09
Showing the 12 most recent of 57 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.