Home NDC 0115-2134 Pyridostigmine Bromide
Product NDC 0115-2134
11-digit product format 001152134
Labeler code 0115
Product ID 0115-2134_83d6b85c-0cd0-467c-90aa-6998f5302559
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 2022-08-08
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 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.
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 0115-2134-01 Pyridostigmine Bromide 21 in 1 BOTTLE TABLET 21 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-2134 PYRIDOSTIGMINE BROMIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240101_91ca7bcf-d2cc-4cb3-bfbe-c294fd707524.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 · 3 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 0115-2134-01 00115213401 21 TABLET in 1 BOTTLE (0115-2134-01) 21 tablet 2022-08-08 0000-00-00 No No Current