Orange Book product · Brand (NDA)
MARCAINE
BUPIVACAINE HYDROCHLORIDE
At a glance
May 04, 1984
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 04, 1984
42 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPIVACAINE HYDROCHLORIDE
Strength
0.75%
Dosage form
INJECTABLE
Route
SPINAL
TE code
AP
Application
NDA 018692
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020XARACOLLBrand (NDA)
NDA 209511 · INNOCOLL PHARMS
- 1992BUPIVACAINE HYDROCHLORIDE KITBrand (NDA)
NDA 019978 · HOSPIRA
- —BUPIVACAINE HYDROCHLORIDEBrand (NDA)
NDA 018053 · HOSPIRA
- —MARCAINE HYDROCHLORIDEBrand (NDA)
NDA 016964 · HOSPIRA
- —SENSORCAINEBrand (NDA)
NDA 018304 · FRESENIUS KABI USA
- 2026BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220493 · ANTHEA PHARMA
- 2024BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217821 · ASPIRO
- 2023BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216040 · MEITHEAL
- 2023BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217792 · SOMERSET
- 2023BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216039 · MEITHEAL
- 2021BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205141 · HIKMA PHARMS
- 2021BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 204842 · HIKMA PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
