Home NDC 0904-6622 pyridostigmine bromide
Product NDC 0904-6622
11-digit product format 009046622
Labeler code 0904
Product ID 0904-6622_6129fcec-1e41-427d-bdba-2653389ac283
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pyridostigmine bromide
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
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 0904-6622-61 pyridostigmine bromide 100 in 1 CARTON TABLET 100 5 0904-6622-61 pyridostigmine bromide 1 in 1 BLISTER PACK TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6622 PYRIDOSTIGMINE BROMIDE TABLET [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20250209_36284496-e56e-466c-9b56-6007bb5bb699.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 0904-6622-61 00904662261 100 BLISTER PACK in 1 CARTON (0904-6622-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2015-08-07 0000-00-00 No No Current