Home NDC 51754-1240-1 Bloxiverz
Product NDC 51754-1240
Requested package NDC 51754-1240-1
11-digit product format 517541240
Labeler code 51754
Product ID 51754-1240_2d69cd60-50c4-4ec3-926e-4d4756ad2c94
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neostigmine methylsulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Exela Pharma Sciences, LLC
Application NDA204078
Marketing category NDA
Marketing start 2021-03-03
Marketing end 0000-00-00
Substance NEOSTIGMINE METHYLSULFATE
Active strength 1 mg/mL
Pharmacologic classes Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51754-1240-3 Bloxiverz 10 in 1 PACKAGE INJECTION 10 2 51754-1240-3 Bloxiverz 1 in 1 CARTON INJECTION 1 2 51754-1240-1 Bloxiverz 1 in 1 CARTON INJECTION 1 1 51754-1240-1 Bloxiverz 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-1240 BLOXIVERZ (NEOSTIGMINE METHYLSULFATE) INJECTION [EXELA PHARMA SCIENCES, LLC] 2 Legacy NDC, 2 package rows 20210508_1fb5c812-1e63-4bd9-a68e-7f9dc5e7a33a.zip 51754-1240 BLOXIVERZ (NEOSTIGMINE METHYLSULFATE) INJECTION [EXELA PHARMA SCIENCES, LLC] 1 Legacy NDC, 2 package rows 20210317_761d8917-27da-4a0c-9acc-98688cbc1d46.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.
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
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 51754-1240-1 51754124001 1 VIAL, MULTI-DOSE in 1 CARTON (51754-1240-1) > 10 mL in 1 VIAL, MULTI-DOSE 2021-03-03 0000-00-00 No No Current