Home NDC 51754-1200-3 Bloxiverz
Product NDC 51754-1200
Requested package NDC 51754-1200-3
11-digit product format 517541200
Labeler code 51754
Product ID 51754-1200_f9ddedaa-a4a1-4fa2-8a3e-a3bb3abdde47
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 2023-11-06
Substance NEOSTIGMINE METHYLSULFATE
Active strength 1 mg/mL
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Bloxiverz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOSTIGMINE METHYLSULFATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98IMH7M386 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311935 Internal RxNorm lookup 311936 Internal RxNorm lookup 1429282 Internal RxNorm lookup 1429284 Internal RxNorm lookup 1668225 Internal RxNorm lookup 2673236 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 51754-1200-3 Bloxiverz 10 in 1 CARTON INJECTION 10 18 51754-1200-3 Bloxiverz 5 mL in 1 SYRINGE, PLASTIC INJECTION 5 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-1200 BLOXIVERZ (NEOSTIGMINE METHYLSULFATE) INJECTION [EXELA PHARMA SCIENCES, LLC] 18 Current NDC, 2 package rows 20240117_d2f55643-2b0d-4ef9-a9d8-b7138b314372.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 Sample Exclude flag Status 51754-1200-3 51754120003 10 SYRINGE, PLASTIC in 1 CARTON (51754-1200-3) / 5 mL in 1 SYRINGE, PLASTIC 2023-12-31 No No Current