Home NDC 51754-4200 Akovaz
Product NDC 51754-4200
11-digit product format 517544200
Labeler code 51754
Product ID 51754-4200_5a627a89-7997-4af5-a1d0-2cedbe1bc868
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ephedrine sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Exela Pharma Sciences, LLC
Application NDA208289
Marketing category NDA
Marketing start 2021-04-15
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 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 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.
Additional Listing Data#
Finished product Yes
Brand name base Akovaz
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116294 Internal RxNorm lookup 1796730 Internal RxNorm lookup 2586841 Internal RxNorm lookup 2586845 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 51754-4200-4 Akovaz 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 4 51754-4200-4 Akovaz 25 in 1 CARTON INJECTION 25 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-4200 AKOVAZ (EPHEDRINE SULFATE) INJECTION [EXELA PHARMA SCIENCES, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20221206_e92f3eda-33eb-4b34-9e8b-db8d32a5dbd9.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51754-4200-4 51754420004 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-4200-4) / 1 mL in 1 VIAL, SINGLE-DOSE 2021-04-15 0000-00-00 No No Current