atropine sulfate NDC 0065-0817

NDC codes

FDA NDC Directory

Product NDC (as listed)0065-0817Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00065-0817Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0065-0817-01	00065081701	1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 2022
0065-0817-02	00065081702	1 BOTTLE, DROPPER in 1 CARTON (0065-0817-02) / 2 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): atropine sulfate
Generic name (nonproprietary): atropine sulfate
Active ingredients: Atropine sulfate — 10 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Alcon Laboratories, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208151
Marketing start: Nov 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0065-0817_96e742ed-f4e5-4e9c-b383-7c8b9fac1a43SPL ID 96e742ed-f4e5-4e9c-b383-7c8b9fac1a43SPL set ID c8093125-ed1a-4eb6-9c81-52c5c7376481RxCUI 1190655UNII 03J5ZE7KA5UPC 0300650817011, 0300650817028
Pharmacologic class: Anticholinergic; Cholinergic Muscarinic Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400065081701 followed by a unit qualifier and the quantity

Package 00065-0817-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 13, 2026.

Indications (excerpt from the label)

Atropine Sulfate Ophthalmic Solution, 1% is indicated for: Atropine Sulfate Ophthalmic Solution, 1% is a muscarinic antagonist indicated for: Mydriasis ( 1.1 ) Cycloplegia ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 ) 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the healthy eye in the treatment of amblyopia

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208151

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 208151
Product	Strength	Form · route	Labeler	Product NDC
Isopto Atropineatropine sulfate	Atropine sulfate 10 mg/mL	SolutionOphthalmic	Alcon Laboratories, Inc.	0065-0303