Home NDC 76014-003-10 Bloxiverz
Product NDC 76014-003
Requested package NDC 76014-003-10
11-digit product format 760140003
Labeler code 76014
Product ID 76014-003_68ac2731-d4be-42a9-a418-e8507853ccc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neostigmine Methylsulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Avadel Legacy Pharmaceuticals, LLC
Application NDA204078
Marketing category NDA
Marketing start 2013-07-24
Marketing end 2023-05-31
Substance NEOSTIGMINE METHYLSULFATE
Active strength 1 mg/mL
Pharmacologic classes Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [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 N204078-001 BLOXIVERZ NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD 2013-05-31 N204078-002 BLOXIVERZ NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2013-05-31 N204078-003 BLOXIVERZ NEOSTIGMINE METHYLSULFATE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27
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 3 · 100 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 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD 2013-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2013-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Socrata Ingredients# 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 Bloxiverz NEOSTIGMINE METHYLSULFATE Exela Pharma Sciences, LLC d2f55643-2b0d-4ef9-a9d8-b7138b314372 2023-12-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 204078 application number: NDA204078
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76014-003-10 76014000310 10 CARTON in 1 PACKAGE (76014-003-10) > 1 VIAL, MULTI-DOSE in 1 CARTON (76014-003-33) > 10 mL in 1 VIAL, MULTI-DOSE 10 carton 2013-07-24 2023-05-31 No No Current