Phenylephrine Hydrochloride NDC 69315-324

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-324Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0324Add 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
69315-324-05	69315032405	1 BOTTLE, DROPPER in 1 CARTON (69315-324-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Sep 5, 2024

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 — 100 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Leading Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215183
Marketing start: Sep 5, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 69315-324_a73191de-c6e0-455f-8e26-f90a529cac56SPL ID a73191de-c6e0-455f-8e26-f90a529cac56SPL set ID 7543f7e8-fd5f-46d5-a310-ebae71becf44RxCUI 1234571, 1234579UNII 04JA59TNSJUPC 0369315324059, 0369315323083, 0369315323151
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

N469315032405 followed by a unit qualifier and the quantity

Package 69315-0324-05. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 215183

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

FDA NDC Directory listings under ANDA 215183
Product	Strength	Form · route	Labeler	Product NDC
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	SolutionOphthalmic	Leading Pharma, LLC	69315-323
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 100 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-150
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-148
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-149
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	SOLA Pharmaceuticals, LLC	70512-865
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 100 mg/mL	Solution/ dropsOphthalmic	SOLA Pharmaceuticals, LLC	70512-866