Home NDC 65841-819 pyridostigmine bromide
Product NDC 65841-819
11-digit product format 658410819
Labeler code 65841
Product ID 65841-819_4f18b45a-d2c9-49d8-ad9e-245c8011615d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pyridostigmine bromide
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA205650
Marketing category ANDA
Marketing start 2015-08-07
Substance PYRIDOSTIGMINE BROMIDE
Active strength 60 mg/1
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 A205650-001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205650-001 AB
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 · 41 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 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205650-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2015-06-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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/1
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 903857 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 65841-819-01 pyridostigmine bromide 100 in 1 BOTTLE TABLET 100 4 65841-819-05 pyridostigmine bromide 500 in 1 BOTTLE TABLET 500 4 65841-819-06 pyridostigmine bromide 30 in 1 BOTTLE TABLET 30 4 65841-819-16 pyridostigmine bromide 90 in 1 BOTTLE TABLET 90 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65841-819 PYRIDOSTIGMINE BROMIDE TABLET [ZYDUS LIFESCIENCES LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20231108_ea4f753f-41a0-4f82-932c-181883d4b6d3.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 · 4 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 65841-819-01 65841081901 100 TABLET in 1 BOTTLE (65841-819-01) 100 tablet 2015-08-07 0000-00-00 No No Current 65841-819-05 65841081905 500 TABLET in 1 BOTTLE (65841-819-05) 500 tablet 2015-08-07 0000-00-00 No No Current 65841-819-06 65841081906 30 TABLET in 1 BOTTLE (65841-819-06) 30 tablet 2015-08-07 0000-00-00 No No Current 65841-819-16 65841081916 90 TABLET in 1 BOTTLE (65841-819-16) 90 tablet 2015-08-07 0000-00-00 No No Current