Home NDC 16571-833 Pryidostigmine Bromide
Product NDC 16571-833
11-digit product format 165710833
Labeler code 16571
Product ID 16571-833_b46177b2-68dc-4958-a4ec-d4bd6d887456
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pyridostigmine Bromide
Dosage form SOLUTION
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA208797
Marketing category ANDA
Marketing start 2022-09-15
Substance PYRIDOSTIGMINE BROMIDE
Active strength 60 mg/5mL
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 A208797-001 PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208797-001 AA
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.
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 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208797-001 PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP / ORAL AA 2020-01-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pryidostigmine Bromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRIDOSTIGMINE BROMIDE 60 mg/5mL
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 903843 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 16571-833-16 Pryidostigmine Bromide 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-833 PRYIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE) SOLUTION [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20220915_beda905e-005a-439d-ac74-92db4e269780.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 16571-833-16 16571083316 473 mL in 1 BOTTLE, PLASTIC (16571-833-16) 473 ml 2022-09-15 0000-00-00 No No Current