Home NDC 43598-945 Neostigmine Methylsulfate
Product NDC 43598-945
11-digit product format 435980945
Labeler code 43598
Product ID 43598-945_7abc7438-a58a-cc92-8fba-36e92389bf58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neostigmine Methylsulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Dr.Reddys Laboratories Inc
Application ANDA216291
Marketing category ANDA
Marketing start 2022-07-25
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216291-001 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216291-001 AP
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.
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 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216291-001 NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-06 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Neostigmine Methylsulfate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2105413 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 43598-945-11 Neostigmine Methylsulfate 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 4 43598-945-11 Neostigmine Methylsulfate 3 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 3 4 43598-945-58 Neostigmine Methylsulfate 10 in 1 CARTON INJECTION, SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-945 NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [DR.REDDYS LABORATORIES INC] 4 Current NDC, Legacy NDC, 3 package rows 20240629_12575d1a-a2c2-37b2-0dcf-31e58bbc2a10.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 Units Marketing start Marketing end Sample Exclude flag Status 43598-945-11 43598094511 1 in 1 BLISTER PACK Historical 43598-945-58 43598094558 10 BLISTER PACK in 1 CARTON (43598-945-58) / 1 SYRINGE, GLASS in 1 BLISTER PACK (43598-945-11) / 3 mL in 1 SYRINGE, GLASS 10 blister pack 2022-07-25 0000-00-00 No No Current