Phenylephrine Hydrochloride NDC 81469-168

NDC codes

FDA NDC Directory

Product NDC (as listed)81469-168Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81469-0168Add 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
81469-168-02	81469016802	1 BOTTLE, DROPPER in 1 CARTON (81469-168-02) / 2 mL in 1 BOTTLE, DROPPERMarketed from Sep 1, 2026
81469-168-15	81469016815	1 BOTTLE, DROPPER in 1 CARTON (81469-168-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from Sep 1, 2026

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): Phenylephrine Hydrochloride
Generic name (nonproprietary): phenylephrine hydrochloride
Active ingredients: Phenylephrine hydrochloride — 25 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: First Nation Group, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216859
Marketing start: Sep 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 81469-168_1972fcbf-76e2-4860-9ffe-6a8ffe662ff9SPL ID 1972fcbf-76e2-4860-9ffe-6a8ffe662ff9
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

N481469016802 followed by a unit qualifier and the quantity

Package 81469-0168-02. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 216859

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

FDA NDC Directory listings under ANDA 216859
Product	Strength	Form · route	Labeler	Product NDC
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	Lifestar Pharma LLC	70756-629
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	NorthStar RxLLC	72603-520
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	Lifestar Pharma LLC	70756-649
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	Lifestar Pharma LLC	70756-676