Home NDC 0065-0817-01 atropine sulfate
Product NDC 0065-0817
Requested package NDC 0065-0817-01
11-digit product format 000650817
Labeler code 0065
Product ID 0065-0817_96e742ed-f4e5-4e9c-b383-7c8b9fac1a43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atropine sulfate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA208151
Marketing category NDA
Marketing start 2022-11-01
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 N208151-001 ISOPTO ATROPINE ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208151-001 AT2
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 · 41 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 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2016-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC 2016-12-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC 2016-12-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC 2016-12-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC 2016-12-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208151-001 ISOPTO ATROPINE 1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-12-01 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 0065-0817-01 atropine sulfate 1 in 1 CARTON SOLUTION 1 8 0065-0817-01 atropine sulfate 5 mL in 1 BOTTLE, DROPPER SOLUTION 5 8 0065-0817-02 atropine sulfate 2 mL in 1 BOTTLE, DROPPER SOLUTION 2 8 0065-0817-02 atropine sulfate 1 in 1 CARTON SOLUTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-0817 ATROPINE SULFATE SOLUTION [ALCON LABORATORIES, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20250124_c8093125-ed1a-4eb6-9c81-52c5c7376481.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 Marketing start Marketing end Sample Exclude flag Status 0065-0817-01 00065081701 1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01) / 5 mL in 1 BOTTLE, DROPPER 2022-11-01 0000-00-00 No No Current