FDA.reportPublic FDA data

Application 218271

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPHEDRINE SULFATEEPHEDRINE SULFATESOLUTION;INTRAVENOUS25MG/5ML (5MG/ML)NoNo
002EPHEDRINE SULFATEEPHEDRINE SULFATESOLUTION;INTRAVENOUS50MG/10ML (5MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A218271-001EPHEDRINE SULFATEEPHEDRINE SULFATE25MG/5ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-11
A218271-002EPHEDRINE SULFATEEPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218271-001AP2
A218271-002AP2

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A218271-001PC2026-02-21
A218271-002PC2026-02-21

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
2026-02-19 14:30 UTC2026-02A218271-001EPHEDRINE SULFATE25MG/5ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218271-002EPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218271-001EPHEDRINE SULFATE25MG/5ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218271-002EPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218271-001EPHEDRINE SULFATE25MG/5ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218271-002EPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218271-001EPHEDRINE SULFATE25MG/5ML (5MG/ML)SOLUTION / INTRAVENOUSAP2025-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218271-002EPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP2025-03-11fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218271-001EPHEDRINE SULFATE25MG/5ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218271-002EPHEDRINE SULFATE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP22025-03-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218271-001AP21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218271-002AP21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218271-001AP2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218271-002AP2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218271-001AP216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218271-002AP216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218271-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218271-002AP1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218271-001AP21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218271-002AP21a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02A218271-001PC2026-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218271-002PC2026-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218271-001PC2026-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218271-002PC2026-02-2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218271-001PC2026-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218271-002PC2026-02-21a50c72e98297…

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ephedrine sulfateEPHEDRINE SULFATEFresenius Kabi USA, LLCc021fe1b-3ac3-4577-b780-f6a3070908a12025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218271
application number: ANDA218271