Home NDC 51662-1717 EPHEDRINE SULFATE
Product NDC 51662-1717
11-digit product format 516621717
Labeler code 51662
Product ID 51662-1717_5fdf6df2-599d-537f-e063-6294a90a7558
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EPHEDRINE SULFATE
Dosage form INJECTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA216146
Marketing category ANDA
Marketing start 2024-11-07
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 45 .
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 A216146-001 EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216146-001 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.
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 2026-11-14 07:37:17 2026-10 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216146-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2022-02-25 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51662-1717-1 51662171701 1 mL in 1 VIAL (51662-1717-1) 1 ml 2024-11-07 No No Current