Prescription drug · ANDA
Cyclogyl (Cyclopentolate hydrochloride) NDC 0065-0396
Cyclopentolate hydrochloride 10 mg/mL · Solution/ drops · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-0396-02 | 0006503960200065039602 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-02) / 2 mL in 1 BOTTLE, PLASTICMarketed from Oct 15, 1975 | |
| 0065-0396-05 | 0006503960500065039605 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-05) / 5 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 — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alcon Laboratories, Inc.NDC labeler code 0065
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084110
- Marketing start
- Listing expires
- Identifiers
- Product ID 0065-0396_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
N400065039602followed by a unit qualifier and the quantityPackage 00065-0396-02. 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: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Excerpt only. Read the full label for complete information.
About NDC 0065-0396
- What is NDC 0065-0396?
- 0065-0396 is the product NDC for Cyclogyl (cyclopentolate hydrochloride), Cyclopentolate hydrochloride 10 mg/mL solution/ drops, listed with the FDA by Alcon Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyclogyl (Cyclopentolate hydrochloride).
- What is the active ingredient?
- Cyclopentolate hydrochloride.
- Who is the labeler?
- Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyclogyl?
- 2 other product NDCs are listed under this name. See all Cyclogyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyclogyl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cyclogylcyclopentolate hydrochloride | Cyclopentolate hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Alcon Laboratories, Inc. | 0065-0395 | 00065-0395-15 |
| Cyclogylcyclopentolate hydrochloride | Cyclopentolate hydrochloride 20 mg/mL | Solution/ dropsOphthalmic | Alcon Laboratories, Inc. | 0065-0397 | 00065-0397-0200065-0397-0500065-0397-15 |
Other NDCs under ANDA 084110
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 |
|---|---|---|---|---|
| Cyclopentolate Hydrochloride | Cyclopentolate hydrochloride 10 mg/mL | SolutionOphthalmic | Sandoz Inc. | 61314-396 |