Orange Book product · Brand (NDA)
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
NOREPINEPHRINE BITARTRATE
At a glance
Feb 06, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 06, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
NOREPINEPHRINE BITARTRATE
Strength
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214313
Product number
004
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.
- 2022NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 214628 · LONG GROVE PHARMS
- 2022NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 215700 · INFORLIFE
- —LEVOPHEDBrand (NDA)
NDA 007513 · HOSPIRA
- 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.
