Home NDC 71863-211 REZIPRES
Product NDC 71863-211
11-digit product format 718630211
Labeler code 71863
Product ID 71863-211_ca19f252-3856-4167-87fe-ef6d928dbe20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ephedrine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eton Pharmaceuticals, Inc.
Application NDA213536
Marketing category NDA
Marketing start 2021-06-14
Marketing end 0000-00-00
Substance EPHEDRINE HYDROCHLORIDE
Active strength 9 mg/mL
Pharmacologic classes alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71863-211-06 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71863-211-06 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71863-211-06 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71863-211-06 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71863-211-06 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71863-211-06 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71863-211-06 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71863-211-06 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71863-211-06 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 71863-211-06 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 71863-211-06 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71863-211-06 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213536-001 REZIPRES EPHEDRINE HYDROCHLORIDE 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 N213536-002 REZIPRES EPHEDRINE HYDROCHLORIDE 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 N213536-003 REZIPRES EPHEDRINE HYDROCHLORIDE 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 N213536-004 REZIPRES EPHEDRINE HYDROCHLORIDE 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07
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.
Product history page 1 of 3 · 120 observed 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 2026-08-18 06:07:40 2026-07 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 d8e5a09893c0…