Mydriacyl (tropicamide) NDC 0065-0355

NDC codes

FDA NDC Directory

Product NDC (as listed)0065-0355Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00065-0355Add 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
0065-0355-03	00065035503	1 BOTTLE in 1 CARTON (0065-0355-03) / 3 mL in 1 BOTTLEMarketed from Apr 1, 1959

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): Mydriacyl
Generic name (nonproprietary): tropicamide
Active ingredients: Tropicamide — 10 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alcon Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 084306
Marketing start: Apr 1, 1959
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 0065-0355_3dd122a9-260c-4d25-9f18-38373ce1b07dSPL ID 3dd122a9-260c-4d25-9f18-38373ce1b07dSPL set ID 57165763-29dc-4812-b840-a8a5086416f3RxCUI 208660, 314238UNII N0A3Z5XTC6UPC 0300650355032
Pharmacologic class: Anticholinergic

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

N400065035503 followed by a unit qualifier and the quantity

Package 00065-0355-03. 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 Dec 22, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 084306

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

FDA NDC Directory listings under ANDA 084306
Product	Strength	Form · route	Labeler	Product NDC
Tropicamide	Tropicamide 10 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc	61314-355
Mydriacyltropicamide	Tropicamide 10 mg/mL	Solution/ dropsOphthalmic	Alcon Laboratories, Inc.	0998-0355