Home NDC 69238-1731-2 Pyridostigmine Bromide
Product NDC 69238-1731
Requested package NDC 69238-1731-2
11-digit product format 692381731
Labeler code 69238
Product ID 69238-1731_c11900df-97bb-47f5-8a29-05fe1586d556
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pyridostigmine Bromide
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA212702
Marketing category ANDA
Marketing start 2020-01-17
Substance PYRIDOSTIGMINE BROMIDE
Active strength 60 mg/5mL
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69238-1731 69238-1731-2 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A212702-001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212702-001 AA
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 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212702-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pyridostigmine Bromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRIDOSTIGMINE BROMIDE 60 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KVI301NA53 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 903843 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 69238-1731-2 Pyridostigmine Bromide 473 mL in 1 BOTTLE SOLUTION 473 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1731 PYRIDOSTIGMINE BROMIDE SOLUTION [AMNEAL PHARMACEUTICALS NY LLC] 8 Current NDC, Legacy NDC, 1 package rows 20240404_9c3a5abf-e217-4292-a305-5afd12b99e95.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 69238-1731-2 69238173102 473 mL in 1 BOTTLE (69238-1731-2) 473 ml 2020-01-17 0000-00-00 No No Current