Prescription drug · ANDA
Phenylephrine Hydrochloride NDC 72603-520
Phenylephrine hydrochloride 25 mg/mL · Solution/ drops · Ophthalmic · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-520-01 | 72603052001 | 1 BOTTLE, DROPPER in 1 CARTON (72603-520-01) / 2 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2024 | |
| 72603-520-02 | 72603052002 | 1 BOTTLE, DROPPER in 1 CARTON (72603-520-02) / 15 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 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 — 25 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216859
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 72603-520_e31ea9e0-264f-451a-84f7-578d3445e2ddSPL ID e31ea9e0-264f-451a-84f7-578d3445e2ddSPL set ID 3ce681eb-8580-49bf-962a-68a576fddd57RxCUI 1234579UNII 04JA59TNSJUPC 0372603520019, 0372603520026
- 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
N472603052001followed by a unit qualifier and the quantityPackage 72603-0520-01. 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 2.5%, 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.
Other NDCs under ANDA 216859
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 | First Nation Group, LLC | 81469-168 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-629 |
| 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 |