Home NDC 14789-250 Emerphed
Product NDC 14789-250
11-digit product format 147890250
Labeler code 14789
Product ID 14789-250_54276f21-7800-44f4-ae51-0060fb1c43ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ephedrine Sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Nexus Pharamaceuticals Inc.
Application NDA213407
Marketing category NDA
Marketing start 2020-05-15
Substance EPHEDRINE SULFATE
Active strength 5 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 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213407-001 EMERPHED EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2020-04-17 N213407-002 EMERPHED EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N213407-001 AP1
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213407-001 11090278 2040-05-16 U-3183 2021-08-13 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 N213407-002 11571398 2040-05-16 U-3183 2023-03-02
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 · 60 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 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2020-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2020-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2020-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 1c564ffb4f44…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 180 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 03ed91905a0d…
Additional Listing Data#
Finished product Yes
Brand name base Emerphed
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPHEDRINE SULFATE 5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2368456 Internal RxNorm lookup 2368461 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 14789-250-07 Emerphed 10 mL in 1 VIAL INJECTION 10 4 14789-250-10 Emerphed 10 in 1 CARTON INJECTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14789-250 EMERPHED (EPHEDRINE SULFATE) INJECTION [NEXUS PHARAMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20221004_e1323592-dc57-4c9d-b84d-442648a7b114.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 · 2 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 14789-250-07 14789025007 10 mL in 1 VIAL 10 ml Historical 14789-250-10 14789025010 10 VIAL in 1 CARTON (14789-250-10) / 10 mL in 1 VIAL (14789-250-07) 10 vial 2020-06-02 0000-00-00 No No Current