Home NDC 71863-210 REZIPRES
Product NDC 71863-210
11-digit product format 718630210
Labeler code 71863
Product ID 71863-210_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 5 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# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 14 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-03-10 12:48 UTC · source 2025-03-10 excluded product product 71863-210 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71863-210 71863-210-06 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 71863-210 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71863-210 71863-210-06 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 71863-210 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71863-210 71863-210-06 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 71863-210 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71863-210 71863-210-06 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 71863-210 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 71863-210 71863-210-06 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 71863-210 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 71863-210 71863-210-06 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 71863-210 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71863-210 71863-210-06 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 116 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 2026-02-19 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…2024-10-29 15:01 UTC 2024-10 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 d06236e962d9…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71863-210-06 71863021006 10 AMPULE in 1 CARTON (71863-210-06) > 5 mL in 1 AMPULE (71863-210-05) 10 ampule 2021-10-01 0000-00-00 No No Current