Home NDC 42023-243 EPHEDRINE SULFATE
Product NDC 42023-243
11-digit product format 420230243
Labeler code 42023
Product ID 42023-243_9e5e9ba2-7ff5-4462-963c-dd92114792e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ephedrine Sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Par Health USA, LLC
Application NDA213994
Marketing category NDA
Marketing start 2021-01-31
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213994-001 EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2020-10-16 N213994-002 EPHEDRINE SULFATE EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2022-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213994-001 10869845 2040-01-22 Drug product 2020-12-22 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 N213994-002 12029710 2040-01-22 U-3963 2024-07-16
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 · 65 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 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2020-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2022-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2020-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2022-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2020-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2022-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2020-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213994-002 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-04-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213994-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-10-16 1c564ffb4f44…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 76 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 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213994-002 12029710 2040-01-22 U-3963 2024-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213994-002 10869845 2040-01-22 Drug product 2022-05-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213994-001 10869845 2040-01-22 Drug product 2020-12-22 5c6f7cd8ea54…
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 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 2586841 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 42023-243-99 EPHEDRINE SULFATE 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 14 42023-243-01 EPHEDRINE SULFATE 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-243 EPHEDRINE SULFATE INJECTION [ENDO USA, INC.] 12 Current NDC, Legacy NDC, 1 package rows 20241122_a247857e-ba7b-4a37-b132-4ba9b0d1c4d1.zip 42023-243 EPHEDRINE SULFATE INJECTION [ENDO USA, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20240425_2c203482-8a04-40fc-93d2-74b30dec7742.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 42023-243-01 42023024301 10 mL in 1 VIAL, SINGLE-DOSE (42023-243-01) 10 ml 2021-01-31 0000-00-00 No No Current 42023-243-99 42023024399 10 mL in 1 VIAL, SINGLE-DOSE (42023-243-99) 10 ml 2024-01-31 No No Current