Phenylephrine Hydrochloride NDC 0065-0343

NDC codes

FDA NDC Directory

Product NDC (as listed)0065-0343Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00065-0343Add 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
0065-0343-02	00065034302	1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 30, 2025

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): Phenylephrine Hydrochloride
Generic name (nonproprietary): phenylephrine hydrochloride
Active ingredients: Phenylephrine hydrochloride — 100 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alcon Laboratories, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 207926
Marketing start: Jan 15, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 0065-0343_c9ffa382-0391-4947-9638-dd7d648a6e38SPL ID c9ffa382-0391-4947-9638-dd7d648a6e38SPL set ID cacbb3fd-1c03-4523-a1bf-0ccc4be102efRxCUI 1234571, 1234579UNII 04JA59TNSJUPC 0300650349048, 0300650343022, 0300650349055
Pharmacologic class: alpha-1 Adrenergic Agonist

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

N400065034302 followed by a unit qualifier and the quantity

Package 00065-0343-02. 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 Apr 1, 2025.

Indications (excerpt from the label)

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 207926

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

FDA NDC Directory listings under NDA 207926
Product	Strength	Form · route	Labeler	Product NDC
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	Alcon Laboratories, Inc.	0065-0349