Home NDC 82260-001-01 Atropine Sulfate
Product NDC 82260-001
Requested package NDC 82260-001-01
11-digit product format 822600001
Labeler code 82260
Product ID 82260-001_4a46793e-5e69-1a65-e063-6294a90a6880
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine Sulfate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Bausch & Lomb Americas Inc.
Application NDA213581
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-04-21
Substance ATROPINE SULFATE
Active strength 10 mg/mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 N213581-001 ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15
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 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213581-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-03-15 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Atropine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATROPINE SULFATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 03J5ZE7KA5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190655 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 82260-001-01 Atropine Sulfate 10 in 1 CARTON SOLUTION 10 4 82260-001-01 Atropine Sulfate 0.4 mL in 1 VIAL SOLUTION 0.4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82260-001 ATROPINE SULFATE SOLUTION [BAUSCH & LOMB AMERICAS INC.] 2 Current NDC, 2 package rows 20250416_e294ce2b-6bb5-4f84-8a6d-ce2402ed926d.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 Sample Exclude flag Status 82260-001-01 82260000101 10 VIAL in 1 CARTON (82260-001-01) / .4 mL in 1 VIAL 10 vial 2023-04-21 No No Current