Home NDC 58657-810-10 Pyridostigmine Bromide
Product NDC 58657-810
Requested package NDC 58657-810-10
11-digit product format 586570810
Labeler code 58657
Product ID 58657-810_41b66d64-08b1-bd0c-e063-6394a90a5b86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PYRIDOSTIGMINE BROMIDE
Dosage form TABLET
Route ORAL
Labeler Method Pharmaceuticals, LLC
Application ANDA211181
Marketing category ANDA
Marketing start 2019-06-01
Substance PYRIDOSTIGMINE BROMIDE
Active strength 30 mg/1
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 · 12 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…
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 A211181-001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 A211181-002 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14
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 3 · 82 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 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2019-05-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2019-05-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2019-05-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2019-05-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2019-05-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2019-05-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211181-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2018-07-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211181-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2019-05-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 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 30 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 903841 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 58657-810-10 Pyridostigmine Bromide 10 in 1 BLISTER PACK TABLET 10 9 58657-810-10 Pyridostigmine Bromide 21 in 1 CARTON TABLET 21 9 58657-810-21 Pyridostigmine Bromide 21 in 1 BOTTLE TABLET 21 9 58657-810-30 Pyridostigmine Bromide 30 in 1 CARTON TABLET 30 9 58657-810-30 Pyridostigmine Bromide 3 in 1 CARTON TABLET 3 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58657-810 PYRIDOSTIGMINE BROMIDE TABLET [METHOD PHARMACEUTICALS, LLC] 8 Current NDC, Legacy NDC, 5 package rows 20241126_e756717f-941b-42f2-ba3b-03798c005ae7.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 · 2 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 58657-810-10 58657081010 21 BLISTER PACK in 1 CARTON (58657-810-10) > 10 TABLET in 1 BLISTER PACK 21 blister pack 2019-06-01 2022-12-31 No No Current