Prescription drug · ANDA
Phenylephrine Hydrochloride NDC 68083-594
Phenylephrine hydrochloride 100 mg/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-594-01 | 68083059401 | 1 BOTTLE, DROPPER in 1 CARTON (68083-594-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from Dec 18, 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/ drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218129
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 68083-594_b31e3905-8ee4-46db-ba72-358ea7d44f10SPL ID b31e3905-8ee4-46db-ba72-358ea7d44f10SPL set ID 2ba80bb2-24f3-4bce-bc04-a6ff4c54fefbRxCUI 1234571, 1234579UNII 04JA59TNSJUPC 0368083680015
- 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
N468083059401followed by a unit qualifier and the quantityPackage 68083-0594-01. 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, USP 2.5% and 10%, 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 218129
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 | Gland Pharma Limited | 68083-680 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Dr.Reddy's Laboratories Inc., | 75907-129 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | Dr.Reddy's Laboratories Inc., | 75907-130 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-593 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Dr.Reddy's Laboratories Inc., | 75907-324 |