Home NDC 68083-670 Atropine
Product NDC 68083-670
11-digit product format 680830670
Labeler code 68083
Product ID 68083-670_01f9b403-5ef9-4364-9138-7e7f65248bde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine Sulfate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Gland Pharma Limited
Application ANDA219996
Marketing category ANDA
Marketing start 2026-07-31
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 43 .
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 A219996-001 ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2026-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219996-001 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 2026-09-14 22:38:34 2026-08 A219996-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2026-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219996-001 ATROPINE SULFATE 1% SOLUTION/DROPS / OPHTHALMIC AT1 2026-07-31 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219996-001 AT1 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219996-001 AT1 1 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Atropine
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68083-670-01 68083067001 1 BOTTLE, DROPPER in 1 CARTON (68083-670-01) / 5 mL in 1 BOTTLE, DROPPER 2026-07-31 No No Current