NDC codes

FDA NDC Directory
Product NDC (as listed)82260-102Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82260-0102Add 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 NDC11-digit (billing)PackageCopy
82260-102-10822600102101 BOTTLE, DROPPER in 1 CARTON (82260-102-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Mar 31, 2023
82260-102-15822600102151 BOTTLE, DROPPER in 1 CARTON (82260-102-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from Mar 31, 2023

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
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 203510
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)
Identifiers
Product ID 82260-102_278d0147-c5b0-4d85-80f5-500ec567feedSPL ID 278d0147-c5b0-4d85-80f5-500ec567feedSPL set ID dcd09e27-93ec-463f-8062-a7dad96c4d0fRxCUI 1234579UNII 04JA59TNSJ
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

N482260010210 followed by a unit qualifier and the quantity

Package 82260-0102-10. 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 .

Indications (excerpt from the label)

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% 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 203510

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

FDA NDC Directory listings under NDA 203510
ProductStrengthForm · routeLabelerProduct NDC
Phenylephrine HydrochloridePhenylephrine hydrochloride 25 mg/mLSolution/ dropsOphthalmicBausch & Lomb Americas Inc.82260-103
Phenylephrine HydrochloridePhenylephrine hydrochloride 25 mg/mLSolution/ dropsOphthalmicParagon BioTeck, Inc.42702-102
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/mLSolution/ dropsOphthalmicParagon BioTeck, Inc.42702-103

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