Orange Book product · Brand (NDA)
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Strength
0.5%;0.0091MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 016964
Product number
008
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.
- 1983SENSORCAINEBrand (NDA)
NDA 018304 · FRESENIUS KABI USA
- 1983BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEBrand (NDA)
NDA 022046 · HOSPIRA
- 2006VIVACAINEGeneric (ANDA)
ANDA 077250 · SEPTODONT
- 1987SENSORCAINEGeneric (ANDA)
ANDA 070966 · FRESENIUS KABI USA
- 1987SENSORCAINEGeneric (ANDA)
ANDA 070967 · FRESENIUS KABI USA
- 1987SENSORCAINEGeneric (ANDA)
ANDA 070968 · FRESENIUS KABI USA
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.
