Home NDC 50090-5197-1 Neostigmine methylsulfate
Product NDC 50090-5197
Requested package NDC 50090-5197-1
11-digit product format 500905197
Labeler code 50090
Product ID 50090-5197_87cc03fb-92c9-460f-881c-c47e89bdb0ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neostigmine methylsulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler A-S Medication Solutions
Application ANDA212968
Marketing category ANDA
Marketing start 2020-09-09
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 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212968-001 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 A212968-002 NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 · 78 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 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212968-001 NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212968-002 NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2019-10-16 782e0a99824c…
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 50090-5197-1 Neostigmine methylsulfate 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 1 50090-5197-1 Neostigmine methylsulfate 1 in 1 CARTON INJECTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5197 NEOSTIGMINE METHYLSULFATE INJECTION [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 2 package rows 20210116_99d11d47-cec0-4374-997b-af97f944636b.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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-5197-1 50090519701 1 VIAL, MULTI-DOSE in 1 CARTON (50090-5197-1) > 10 mL in 1 VIAL, MULTI-DOSE 2020-10-01 0000-00-00 No No Current