isopto atropine
Generic: atropine sulfate
Labeler: alcon laboratories, inc.Drug Facts
Product Profile
Brand Name
isopto atropine
Generic Name
atropine sulfate
Labeler
alcon laboratories, inc.
Dosage Form
SOLUTION
Routes
Active Ingredients
atropine sulfate 10 mg/mL
Manufacturer
Identifiers & Regulatory
Product NDC
0065-0303
Product ID
0065-0303_b3493429-e973-4c38-8e7b-23376075bd20
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA208151
Listing Expiration
2026-12-31
Marketing Start
2018-08-01
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
00650303
Hyphenated Format
0065-0303
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
isopto atropine (source: ndc)
Generic Name
atropine sulfate (source: ndc)
Application Number
NDA208151 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 10 mg/mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING ISOPTO® Atropine 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER® dispensers with low-density polyethylene tips and red polypropylene caps as follows: 5 mL filled in 8-mL bottles NDC 0065-0303-55 Storage: Store ISOPTO® Atropine 1% at 2–25°C (36–77°F).
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0065-0303-55 Alcon ® Isopto ® Atropine (atropine sulfate ophthalmic solution) 1% 5 mL Sterile USUAL ADULT DOSAGE: One drop topically in the eye(s) up to twice daily. For other dosage information, read enclosed insert. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°-25°C (36°-77°F). Read enclosed insert. Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1.0%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. © 2003, 2018 Novartis Alcon ® ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Germany 9016388-0618 SN: LOT: EXP.: GTIN: 00300650303552 NDC 0065-0303-55 Alcon ® Isopto ® Atropine (atropine sulfate ophthalmic solution) 1% Sterile 5mL Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1.0%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. USUAL ADULT DOSAGE: One drop topically in the eye(s) up to twice daily. For other dosage information, read enclosed insert. FOR TOPICAL OPHTHALMIC USE. STORAGE: Store at 2°-25°C (36°-77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA ©2018 Novartis H15250-0318
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "b3493429-e973-4c38-8e7b-23376075bd20", "openfda": {"unii": ["03J5ZE7KA5"], "rxcui": ["1190655", "1190664"], "spl_set_id": ["20491566-e6eb-8d4a-3083-77ea429f7bc4"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Isopto Atropine", "product_id": "0065-0303_b3493429-e973-4c38-8e7b-23376075bd20", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0065-0303", "generic_name": "atropine sulfate", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isopto Atropine", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": "10 mg/mL"}], "application_number": "NDA208151", "marketing_category": "NDA", "marketing_start_date": "20180801", "listing_expiration_date": "20261231"}