Orange Book product · Brand (NDA)
LEVOPHED
NOREPINEPHRINE 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
NOREPINEPHRINE BITARTRATE
Strength
EQ 1MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 007513
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.
- 2026NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 214313 · BAXTER HLTHCARE CORP
- 2022NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 214628 · LONG GROVE PHARMS
- 2022NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 215700 · INFORLIFE
- 2026NOREPINEPHRINE BITARTRATEGeneric (ANDA)
ANDA 216272 · NEPHRON
- 2026NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEGeneric (ANDA)
ANDA 220483 · SAGENT
- 2025NOREPINEPHRINE BITARTRATEGeneric (ANDA)
ANDA 218595 · MSN
- 2025NOREPINEPHRINE BITARTRATEGeneric (ANDA)
ANDA 219924 · ANTHEA PHARMA
- 2025NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEGeneric (ANDA)
ANDA 219692 · SAGENT
- 2025NOREPINEPHRINE BITARTRATEGeneric (ANDA)
ANDA 219443 · BIOCON PHARMA
- 2025NOREPINEPHRINE BITARTRATEGeneric (ANDA)
ANDA 219163 · ASPIRO
- 2024NOREPINEPHRINE BITARTRATEGeneric (ANDA)
ANDA 218758 · RISING
- 2023NOREPINEPHRINE BITARTRATEGeneric (ANDA)
ANDA 217575 · CAPLIN
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.
