FDA.reportPublic FDA data

Application 219692

Type
ANDA
Sponsor
SAGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOREPINEPHRINE BITARTRATE IN 5% DEXTROSENOREPINEPHRINE BITARTRATESOLUTION;INTRAVENOUSEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)NoNo
002NOREPINEPHRINE BITARTRATE IN 5% DEXTROSENOREPINEPHRINE BITARTRATESOLUTION;INTRAVENOUSEQ 8MG BASE/250ML (EQ 32MCG BASE/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219692-001NOREPINEPHRINE BITARTRATE IN 5% DEXTROSENOREPINEPHRINE BITARTRATEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-11
A219692-002NOREPINEPHRINE BITARTRATE IN 5% DEXTROSENOREPINEPHRINE BITARTRATEEQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219692-001AP
A219692-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219692-001NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A219692-002NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A219692-001NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A219692-002NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219692-001NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219692-002NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219692-001NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219692-002NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-1131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219692-001NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219692-002NOREPINEPHRINE BITARTRATE IN 5% DEXTROSEEQ 8MG BASE/250ML (EQ 32MCG BASE/ML)SOLUTION / INTRAVENOUSAP2025-08-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219692-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A219692-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A219692-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219692-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219692-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219692-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219692-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219692-002AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219692-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219692-002AP1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norepinephrine BitartrateNOREPINEPHRINE BITARTRATEFresenius Kabi USA, LLCdfed53ef-2060-44b8-a62e-9f8ee10a05a52023-06-05Warnings, Adverse reactionsName fallback
generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATENOREPINEPHRINE BITARTRATECivica, Inc.4408987e-690a-41ac-9677-e24604fa97932023-03-31Warnings, Adverse reactionsName fallback
generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATENOREPINEPHRINE BITARTRATESandoz Inc728734e7-1684-4b37-980c-f1dfd408b4362022-03-01Warnings, Adverse reactionsName fallback
generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine bitartrateNOREPINEPHRINE BITARTRATEMylan Institutional LLCd3ea12e0-88cc-49b0-b06e-5199ecd6ca692021-10-15Warnings, Adverse reactionsName fallback
generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATENOREPINEPHRINE BITARTRATESun Pharmaceutical Industries, Inc.4bb42f07-a41e-42f3-92e7-dab665584f842021-07-01Warnings, Adverse reactionsName fallback
generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine BitartrateNOREPINEPHRINE BITARTRATEBaxter Healthcare Companye375a0b9-4d26-4749-bbc3-43d63a7cf65a2021-05-06Warnings, Adverse reactionsName fallback
generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine bitartrateNOREPINEPHRINE BITARTRATEMylan Institutional LLC7a4950ea-6369-4dd5-97be-df21a5a5055f2021-03-05Warnings, Adverse reactionsName fallback
generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine BitartrateNOREPINEPHRINE BITARTRATEFresenius Kabi USA, LLCc297757e-35ff-4f39-bccd-61002ac51e232020-12-02Warnings, Adverse reactionsName fallback
generic name: NOREPINEPHRINE BITARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.