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FDA Orange Book · active-ingredient family

Norepinephrine bitartrate

Norepinephrine bitartrate: 4 brands, 22 generics; first approved Mar 03, 2003; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 22 ANDA applications approved.

Earliest patent expiry Feb 26, 2035
Brands (NDA)
4
Generics (ANDA)
22
Listed patents
12
Next patent expiry
Feb 26, 2035
in 8 yr 9 mo
Originator applications

Brand (NDA) products

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDERLDRS
NDA 21431320266 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTIONINTRAVENOUSRxAP
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTIONINTRAVENOUSRxAP
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTIONINTRAVENOUSRxAP
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDERLDRS
NDA 21462820223 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDERLDRS
NDA 21570020224 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
EQ 32MG BASE/250ML (EQ 128MCG BASE/ML)SOLUTIONINTRAVENOUSRx—
LEVOPHEDRLDRS
NDA 007513—
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
Abbreviated applications

Generic (ANDA) products (22)

NOREPINEPHRINE BITARTRATE
ANDA 2162722026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
ANDA 2204832026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTIONINTRAVENOUSRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2185952025
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2199242025
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
ANDA 21969220252 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTIONINTRAVENOUSRxAP
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTIONINTRAVENOUSRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2194432025
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2191632025
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2187582024
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2175752023
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2163412022
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONDiscontinued—
NOREPINEPHRINE BITARTRATE
ANDA 2143232021
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2119802021
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONDiscontinued—
NOREPINEPHRINE BITARTRATE
ANDA 2144552021
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2113822020
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2108392018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2036622018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2113592018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 2112422018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 0408592012
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 0405222004
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONDiscontinued—
NOREPINEPHRINE BITARTRATE
ANDA 0404622003
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
NOREPINEPHRINE BITARTRATE
ANDA 0404552003
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASE/MLINJECTABLEINJECTIONRxAP
Protection horizon

Patent & exclusivity timeline

202620282030203220342036203820402042TodayPatent RE49422 — 2035-02-26Patent RE49422Patent RE49443 — 2035-02-26Patent RE49443Patent 11413259 — 2038-01-30Patent 11413259Patent 10420735 — 2038-01-30Patent 10420735Patent 10226436 — 2038-01-30Patent 10226436Patent 12245996 — 2038-01-30Patent 12245996Patent 10568850 — 2038-01-30Patent 10568850Patent 10159657 — 2038-01-30Patent 10159657Patent 11602508 — 2038-01-30Patent 11602508Patent 10888534 — 2039-04-26Patent 10888534Patent 12097170 — 2041-03-08Patent 12097170Patent 12290494 — 2041-03-08Patent 12290494
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
RE49422Feb 26, 2035in 8 yr 9 mo
Product
RE49443Feb 26, 2035in 8 yr 9 mo
Product
11413259Jan 30, 2038in 11 yr 9 mo
ProductU-3461
10420735Jan 30, 2038in 11 yr 9 mo
ProductU-3461
10226436Jan 30, 2038in 11 yr 9 mo
ProductU-3461
12245996Jan 30, 2038in 11 yr 9 mo
Product
10568850Jan 30, 2038in 11 yr 9 mo
Product
10159657Jan 30, 2038in 11 yr 9 mo
Product
11602508Jan 30, 2038in 11 yr 9 mo
Product
10888534Apr 26, 2039in 13 yr
Product
12097170Mar 08, 2041in 14 yr 10 mo
ProductU-3995
12290494Mar 08, 2041in 14 yr 10 mo
Product
FDA approval span

Approval history

First approval
Mar 03, 2003
23 yr 8 mo ago
Most recent approval
Jun 11, 2026
1 mo ago

Approvals span 2003–2026 across 26 FDA applications.

Brand (NDA) 415%
Generic (ANDA) 2285%

Norepinephrine bitartrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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