Home NDC 42799-826-01 Atropine sulfate
Product NDC 42799-826
Requested package NDC 42799-826-01
11-digit product format 427990826
Labeler code 42799
Product ID 42799-826_0e312e98-b1a3-4746-b074-b0cd28aba14e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine sulfate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Edenbridge Pharmaceuticals LLC.
Application ANDA219013
Marketing category ANDA
Marketing start 2026-05-06
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 A219013-001 ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2026-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219013-001 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219013-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2026-04-15 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219013-001 AT1 1 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 42799-826-01 Atropine sulfate 2 mL in 1 BOTTLE SOLUTION/ DROPS 2 2 42799-826-01 Atropine sulfate 1 in 1 CARTON SOLUTION/ DROPS 1 2 42799-826-02 Atropine sulfate 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 2 42799-826-02 Atropine sulfate 1 in 1 CARTON SOLUTION/ DROPS 1 2 42799-826-03 Atropine sulfate 1 in 1 CARTON SOLUTION/ DROPS 1 2 42799-826-03 Atropine sulfate 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 2
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 42799-826-01 42799082601 1 BOTTLE in 1 CARTON (42799-826-01) / 2 mL in 1 BOTTLE 1 bottle 2026-05-06 No No Current