Prescription drug · ANDA
Cyclomydril NDC 0065-0359
cyclopentolate hydrochloride and phenylephrine hydrochloride · Cyclopentolate hydrochloride 2 mg/mL; Phenylephrine hydrochloride 10 mg/mL · Solution/ drops · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-0359-02 | 00065035902 | 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02)Marketed from Jun 30, 1958 | |
| 0065-0359-05 | 00065035905 | 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05)Marketed from Jun 30, 1958 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Cyclomydril
- Generic name (nonproprietary)
- cyclopentolate hydrochloride and phenylephrine hydrochloride
- Active ingredients
- Cyclopentolate hydrochloride — 2 mg/mLPhenylephrine hydrochloride — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alcon Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084300
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 0065-0359_3c5dad7d-4db2-4615-92cb-01ea4d769adfSPL ID 3c5dad7d-4db2-4615-92cb-01ea4d769adfSPL set ID 8268b70f-3f10-48dd-bb24-baaeb27a1325RxCUI 1298068, 1298360UNII 736I6971TE, 04JA59TNSJUPC 0300650359054
- 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
N400065035902followed by a unit qualifier and the quantityPackage 00065-0359-02. 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)
INDICATIONS AND USAGE For the production of mydriasis.
Excerpt only. Read the full label for complete information.