What is NDC 0065-0303?

0065-0303 is the product NDC for Isopto Atropine (atropine sulfate), Atropine sulfate 10 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc..

What drug is associated with this NDC?

Isopto Atropine (Atropine sulfate).

Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Isopto Atropine?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isopto Atropine NDC 0065-0303 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0065-0303Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00065-0303Add the package segment from the table below.

Product information

Brand name (proprietary): Isopto Atropine
Generic name (nonproprietary): atropine sulfate
Active ingredients: Atropine sulfate — 10 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Alcon Laboratories, Inc.NDC labeler code 0065
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208151
Marketing start: Aug 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0065-0303_b3493429-e973-4c38-8e7b-23376075bd20SPL ID b3493429-e973-4c38-8e7b-23376075bd20SPL set ID 20491566-e6eb-8d4a-3083-77ea429f7bc4RxCUI 1190655, 1190664UNII 03J5ZE7KA5
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.

Product label

Current FDA label (SPL), effective Oct 7, 2022.

Indications (excerpt from the label)

ISOPTO ® Atropine 1% is indicated for: ISOPTO® Atropine 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)

About NDC 0065-0303

What is NDC 0065-0303?: 0065-0303 is the product NDC for Isopto Atropine (atropine sulfate), Atropine sulfate 10 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc..
What drug is associated with this NDC?: Isopto Atropine (Atropine sulfate).
What is the active ingredient?: Atropine sulfate.
Who is the labeler?: Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Isopto Atropine?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
atropine sulfate	Atropine sulfate 10 mg/mL	SolutionOphthalmic	Alcon Laboratories, Inc.	0065-0817

Isopto Atropine (Atropine sulfate) NDC 0065-0303