FDA.reportPublic FDA data

REZIPRES

Product NDC
39822-1410
11-digit product format
398221410
Labeler code
39822
Product ID
39822-1410_109f0168-154e-4fc1-8ab2-cd6aeacd87f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, 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 productproduct39822-1410DDiscontinued by firm2026-08-03
excluded packagepackage39822-141039822-1410-6DDiscontinued by firm2026-08-03

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-1410-5ML - Milliliter39822-1410362c69a2-45f1-493c-ba0f-0bb010711fb912022-04-06
39822-1410-6ML - Milliliter39822-1410e51fad69-5e22-458e-bf79-b6f17a4156fa12022-04-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-1410-63982214100610 AMPULE in 1 CARTON (39822-1410-6) > 5 mL in 1 AMPULE (39822-1410-5) 10 ampule2021-11-010000-00-00NoNoCurrent