Home NDC 76014-005-25 Akovaz
Product NDC 76014-005
Requested package NDC 76014-005-25
11-digit product format 760140005
Labeler code 76014
Product ID 76014-005_26f0bc51-fbc5-4d99-9972-6344f51f64a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ephedrine sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Avadel Legacy Pharmaceuticals, LLC
Application NDA208289
Marketing category NDA
Marketing start 2016-08-01
Marketing end 2023-09-30
Substance EPHEDRINE SULFATE
Active strength 50 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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N208289-001 AKOVAZ EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 N208289-002 AKOVAZ EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 RLD, RS 2021-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 74 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 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 RLD, RS 2021-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 RLD, RS 2021-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 RLD, RS 2021-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Akovaz EPHEDRINE SULFATE Exela Pharma Sciences, LLC e92f3eda-33eb-4b34-9e8b-db8d32a5dbd9 2020-11-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 208289 application number: NDA208289
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 76014-005-25 76014000525 25 VIAL, SINGLE-DOSE in 1 CARTON (76014-005-25) > 1 mL in 1 VIAL, SINGLE-DOSE (76014-005-30) 2016-08-01 2023-09-30 No No Current