Home NDC 60219-1750-8 Atropine
Product NDC 60219-1750
Requested package NDC 60219-1750-8
11-digit product format 602191750
Labeler code 60219
Product ID 60219-1750_1b2b68ed-bad1-4742-b88d-1d2f0040ad52
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atropine sulfate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA214752
Marketing category ANDA
Marketing start 2022-07-19
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 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 A214752-001 ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214752-001 AT1
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 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT RS 2022-07-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT RS 2022-07-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT RS 2022-07-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT RS 2022-07-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT RS 2022-07-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT 2022-07-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT 2022-07-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT 2022-07-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT 2022-07-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT 2022-07-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT 2022-07-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT 2022-07-14 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214752-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 RS 2022-07-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Atropine
Listing expiration 2026-12-31 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 60219-1750-8 Atropine 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 10 60219-1750-8 Atropine 1 in 1 CARTON SOLUTION/ DROPS 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-1750 ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC] 8 Current NDC, Legacy NDC, 2 package rows 20240707_f8718be5-8fa4-4c36-a4fd-fac7c3953f5a.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 60219-1750-8 60219175008 1 BOTTLE, DROPPER in 1 CARTON (60219-1750-8) / 15 mL in 1 BOTTLE, DROPPER 2022-07-19 0000-00-00 No No Current