Home NDC 62559-470 Pyridostigmine Bromide
Product NDC 62559-470
11-digit product format 625590470
Labeler code 62559
Product ID 62559-470_138c3e38-dc2d-46be-8ee6-bef9221a971c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pyridostigmine Bromide
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA040512
Marketing category ANDA
Marketing start 2024-01-16
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 A040512-001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 A040512-002 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040512-001 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 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 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL AB 2003-10-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040512-001 PYRIDOSTIGMINE BROMIDE 60MG TABLET / ORAL 2003-10-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040512-002 PYRIDOSTIGMINE BROMIDE 30MG TABLET / ORAL 2005-07-20 782e0a99824c…
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/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 62559-470-01 Pyridostigmine Bromide 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-470 PYRIDOSTIGMINE BROMIDE TABLET [ANI PHARMACEUTICALS, INC.] 2 Current NDC, 1 package rows 20240117_0a114d99-e50b-49fe-9e0f-ccce279ffb4f.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 Sample Exclude flag Status 62559-470-01 62559047001 100 TABLET in 1 BOTTLE (62559-470-01) 100 tablet 2024-01-16 No No Current