Prescription drug · NDA AUTHORIZED GENERIC
Phenylephrine Hydrochloride NDC 82260-102
Phenylephrine hydrochloride 25 mg/mL · Solution/ drops · Ophthalmic · Bausch & Lomb Americas Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82260-102-10 | 82260010210 | 1 BOTTLE, DROPPER in 1 CARTON (82260-102-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Mar 31, 2023 | |
| 82260-102-15 | 82260010215 | 1 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
- Labeler
- Bausch & Lomb Americas Inc.
- 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
N482260010210followed by a unit qualifier and the quantityPackage 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.
Other NDCs under NDA 203510
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Americas Inc. | 82260-103 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Paragon BioTeck, Inc. | 42702-102 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | Paragon BioTeck, Inc. | 42702-103 |