Home NDC 0115-3511-01 Pyridostigmine Bromide
Product NDC 0115-3511
Requested package NDC 0115-3511-01
11-digit product format 001153511
Labeler code 0115
Product ID 0115-3511_3d2e45fb-a83b-4e76-b1cd-9caf2b00a804
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PYRIDOSTIGMINE BROMIDE
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA040502
Marketing category ANDA
Marketing start 2003-04-24
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040502-001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 A040502-002 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28
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 · 69 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 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040502-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL AB 2022-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040502-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-04-24 b00525d2431f…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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 0115-3511-01 Pyridostigmine Bromide 100 in 1 BOTTLE TABLET 100 17 0115-3511-02 Pyridostigmine Bromide 500 in 1 BOTTLE TABLET 500 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-3511 PYRIDOSTIGMINE BROMIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 16 Current NDC, Legacy NDC, 2 package rows 20241211_0f56facf-1f0a-4ba5-876d-757b114dfa45.zip
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 0115-3511-01 00115351101 100 TABLET in 1 BOTTLE (0115-3511-01) 100 tablet 2003-04-24 0000-00-00 No No Current