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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71863-210DDiscontinued by firm2026-08-03
excluded packagepackage71863-21071863-210-06DDiscontinued by firm2026-08-03

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct71863-210DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71863-21071863-210-06DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct71863-210DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71863-21071863-210-06DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct71863-210DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71863-21071863-210-06DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct71863-210DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71863-21071863-210-06DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct71863-210DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71863-21071863-210-06DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct71863-210DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71863-21071863-210-06DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct71863-210DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71863-21071863-210-06DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213536-001REZIPRESEPHEDRINE HYDROCHLORIDE23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14
N213536-002REZIPRESEPHEDRINE HYDROCHLORIDE47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14
N213536-003REZIPRESEPHEDRINE HYDROCHLORIDE47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14
N213536-004REZIPRESEPHEDRINE HYDROCHLORIDE47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2023-12-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2023-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2023-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2023-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213536-001REZIPRES23.5MG/5ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N213536-002REZIPRES47MG/ML (47MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N213536-003REZIPRES47MG/5ML (9.4MG/ML)SOLUTION / INTRAVENOUSRLD2021-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N213536-004REZIPRES47MG/10ML (4.7MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-12-07d06236e962d9…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71863-210-067186302100610 AMPULE in 1 CARTON (71863-210-06) > 5 mL in 1 AMPULE (71863-210-05) 10 ampule2021-10-010000-00-00NoNoCurrent