Tropicamide NDC 61314-354

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-354Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0354Add 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
61314-354-01	61314035401	1 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) / 15 mL in 1 BOTTLE, PLASTICMarketed from Jun 9, 2000

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Tropicamide
Generic name (nonproprietary): tropicamide
Active ingredients: Tropicamide — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 084305
Marketing start: Jun 9, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 61314-354_2fbad93e-d3da-4a31-9a78-66a923ce78baSPL ID 2fbad93e-d3da-4a31-9a78-66a923ce78baSPL set ID 521592d1-53a1-4314-8b3f-d808f3bccfcdRxCUI 313521UNII N0A3Z5XTC6
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

N461314035401 followed by a unit qualifier and the quantity

Package 61314-0354-01. 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 Jan 26, 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)