Home NDC 76014-004-33 Vazculep
Product NDC 76014-004
Requested package NDC 76014-004-33
11-digit product format 760140004
Labeler code 76014
Product ID 76014-004_7d95aa48-b7dd-4bc2-b684-9dca6d3a13cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenylephrine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Avadel Legacy Pharmaceuticals, LLC
Application NDA204300
Marketing category NDA
Marketing start 2014-07-01
Marketing end 2023-06-30
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204300-001 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2014-06-27 N204300-002 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2014-06-27 N204300-003 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2014-06-27
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 4 · 123 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 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2014-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2014-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2014-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2014-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2014-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2014-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204300-002 VAZCULEP 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204300-003 VAZCULEP 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204300-001 VAZCULEP 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2014-06-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8 WATER INACTIVE INGREDIENT 059QF0KO0R VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [ÉCLAT PHARMACEUTICALS, LLC] 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 76014-004-33 76014000433 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (76014-004-33) > 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2014-07-01 2023-06-30 No No Current