Prescription drug · NDA
Phenylephrine Hydrochloride NDC 42702-103
Phenylephrine hydrochloride 100 mg/mL · Solution/ drops · Ophthalmic · Paragon BioTeck, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42702-103-05 | 42702010305 | 1 BOTTLE, DROPPER in 1 CARTON (42702-103-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 15, 2013 |
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/ drops
- Route
- Ophthalmic
- Labeler
- Paragon BioTeck, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203510
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 42702-103_ff463c02-5533-c9ad-e053-6294a90a7035SPL ID ff463c02-5533-c9ad-e053-6294a90a7035SPL set ID a4d3fe20-f063-11e0-ac29-0002a5d5c51bRxCUI 1234571, 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
N442702010305followed by a unit qualifier and the quantityPackage 42702-0103-05. 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
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. | 82260-102 |
| 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 |