What is NDC 61314-355?

61314-355 is the product NDC for Tropicamide, Tropicamide 10 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tropicamide?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tropicamide NDC 61314-355 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-355Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0355Add 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
61314-355-01	6131403550161314035501	1 BOTTLE, PLASTIC in 1 CARTON (61314-355-01) / 3 mL in 1 BOTTLE, PLASTICMarketed from Jun 13, 2000
61314-355-02	6131403550261314035502	1 BOTTLE, PLASTIC in 1 CARTON (61314-355-02) / 15 mL in 1 BOTTLE, PLASTICMarketed from Jun 13, 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 — 10 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Sandoz IncNDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 084306
Marketing start: Jun 13, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 61314-355_51620df4-8e34-4ffa-bf5a-077efc3a1911SPL ID 51620df4-8e34-4ffa-bf5a-077efc3a1911SPL set ID 0104ffe4-013d-4afa-996d-dcba4f08e93dRxCUI 314238UNII 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

N461314035501 followed by a unit qualifier and the quantity

Package 61314-0355-01. 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 Jun 29, 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)

About NDC 61314-355

What is NDC 61314-355?: 61314-355 is the product NDC for Tropicamide, Tropicamide 10 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tropicamide.
What is the active ingredient?: Tropicamide.
Who is the labeler?: Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tropicamide?: 7 other product NDCs are listed under this name. See all Tropicamide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tropicamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tropicamide	Tropicamide 10 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-121	70069-0121-01
Tropicamide	Tropicamide 10 mg/mL	Solution/ dropsOphthalmic	Sportpharm LLC	85766-040	85766-0040-15
Tropicamide	Tropicamide 5 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc	61314-354	61314-0354-01
Tropicamide	Tropicamide 10 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-585	24208-0585-5924208-0585-64
Tropicamide	Tropicamide 5 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-590	24208-0590-64
Tropicamide	Tropicamide 10 mg/mL	Solution/ dropsOphthalmic	Sportpharm LLC	85766-278	85766-0278-15
Tropicamide	Tropicamide 5 mg/mL	Solution/ dropsOphthalmic	Sportpharm LLC	85766-279	85766-0279-15

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
Mydriacyltropicamide	Tropicamide 10 mg/mL	Solution/ dropsOphthalmic	Alcon Laboratories, Inc.	0065-0355
Mydriacyltropicamide	Tropicamide 10 mg/mL	Solution/ dropsOphthalmic	Alcon Laboratories, Inc.	0998-0355