Home NDC 42023-216 Ephedrine Sulfate
Product NDC 42023-216
11-digit product format 420230216
Labeler code 42023
Product ID 42023-216_3aaa566f-1bff-4084-8578-60e1b66013e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ephedrine Sulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Par Health USA, LLC
Application NDA208943
Marketing category NDA
Marketing start 2017-02-16
Substance EPHEDRINE SULFATE
Active strength 50 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 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208943-001 CORPHEDRA EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208943-001 AP
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 2 · 41 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 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208943-001 CORPHEDRA 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2017-01-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ephedrine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPHEDRINE SULFATE 50 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116294 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 42023-216-01 Ephedrine Sulfate 1 mL in 1 VIAL INJECTION, SOLUTION 1 10 42023-216-25 Ephedrine Sulfate 25 in 1 CARTON INJECTION, SOLUTION 25 10 42023-216-83 Ephedrine Sulfate 25 in 1 CARTON INJECTION, SOLUTION 25 7 42023-216-83 Ephedrine Sulfate 1 mL in 1 VIAL INJECTION, SOLUTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-216 EPHEDRINE SULFATE INJECTION, SOLUTION [ENDO USA, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240425_38723cb3-dfca-4c81-8c6f-63dd99929191.zip 42023-216 EPHEDRINE SULFATE INJECTION, SOLUTION [ENDO USA, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241018_3e43cc8e-bf4e-44ef-a07d-4336367b9bdb.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42023-216-01 42023021601 1 mL in 1 VIAL 1 ml Historical 42023-216-25 42023021625 25 VIAL in 1 CARTON (42023-216-25) / 1 mL in 1 VIAL (42023-216-01) 25 vial 2017-02-16 0000-00-00 No No Current 42023-216-83 42023021683 25 VIAL in 1 CARTON (42023-216-83) / 1 mL in 1 VIAL 25 vial 2018-06-26 0000-00-00 No No Current