Home NDC 70069-583-01 Atropine sulfate
Product NDC 70069-583
Requested package NDC 70069-583-01
11-digit product format 700690583
Labeler code 70069
Product ID 70069-583_43d3dd59-36b1-493f-86a3-c5eee9750ee8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine sulfate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Somerset Therapeutics, LLC
Application ANDA215618
Marketing category ANDA
Marketing start 2025-02-12
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 A215618-001 ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215618-001 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 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215618-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2024-07-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Atropine sulfate
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 70069-583-01 Atropine sulfate 1 in 1 CARTON SOLUTION/ DROPS 1 8 70069-583-01 Atropine sulfate 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 8
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 · 1 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 70069-583-01 70069058301 1 BOTTLE in 1 CARTON (70069-583-01) / 15 mL in 1 BOTTLE 1 bottle 2025-02-12 No No Current