Cyclogyl (cyclopentolate hydrochloride) NDC 0065-0397

NDC codes

FDA NDC Directory

Product NDC (as listed)0065-0397Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00065-0397Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0065-0397-02	00065039702	1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-02) / 2 mL in 1 BOTTLE, PLASTICMarketed from Oct 15, 1975
0065-0397-05	00065039705	1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Oct 15, 1975
0065-0397-15	00065039715	1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-15) / 15 mL in 1 BOTTLE, PLASTICMarketed from Oct 15, 1975

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): Cyclogyl
Generic name (nonproprietary): cyclopentolate hydrochloride
Active ingredients: Cyclopentolate hydrochloride — 20 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 084108
Marketing start: Oct 15, 1975
Listing expires: Dec 31, 2026
Identifiers: Product ID 0065-0397_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1SPL ID 2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1SPL set ID 1d008c76-7210-4ace-90fa-7cd22762e12eRxCUI 1298066, 1298070, 1298072, 1298356, 1298364, 1298366UNII 736I6971TEUPC 0300650396059

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

N400065039702 followed by a unit qualifier and the quantity

Package 00065-0397-02. 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 Jun 25, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)