Home NDC 65219-548 ephedrine sulfate
Product NDC 65219-548
11-digit product format 652190548
Labeler code 65219
Product ID 65219-548_de95d79e-ae15-4056-a4e5-ac3380768cdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ephedrine sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA218271
Marketing category ANDA
Marketing start 2025-07-07
Substance EPHEDRINE SULFATE
Active strength 5 mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218271-001 EPHEDRINE SULFATE EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 A218271-002 EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A218271-001 PC 2026-02-21 A218271-002 PC 2026-02-21
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218271-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218271-002 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218271-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218271-002 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218271-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218271-002 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218271-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218271-002 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-11 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218271-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218271-002 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 2025-03-11 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218271-001 PC 2026-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218271-002 PC 2026-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218271-001 PC 2026-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218271-002 PC 2026-02-21 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218271-001 PC 2026-02-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218271-002 PC 2026-02-21 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base ephedrine sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPHEDRINE SULFATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U6X61U5ZEG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2586841 Internal RxNorm lookup 2631017 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-548-01 ephedrine sulfate 10 mL in 1 SYRINGE, PLASTIC INJECTION 10 1 65219-548-10 ephedrine sulfate 10 in 1 CARTON INJECTION 10 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-548-01 65219054801 10 mL in 1 SYRINGE, PLASTIC 10 ml Historical 65219-548-10 65219054810 10 SYRINGE, PLASTIC in 1 CARTON (65219-548-10) / 10 mL in 1 SYRINGE, PLASTIC (65219-548-01) 2025-07-07 No No Current