Prescription drug · ANDA
Mydriacyl (Tropicamide) NDC 0065-0355
Tropicamide 10 mg/mL · Solution/ drops · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-0355-03 | 00065035503 | 1 BOTTLE in 1 CARTON (0065-0355-03) / 3 mL in 1 BOTTLEMarketed from Apr 1, 1959 |
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)
- Mydriacyl
- Generic name (nonproprietary)
- tropicamide
- Active ingredients
- Tropicamide — 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 084306
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 0065-0355_3dd122a9-260c-4d25-9f18-38373ce1b07dSPL ID 3dd122a9-260c-4d25-9f18-38373ce1b07dSPL set ID 57165763-29dc-4812-b840-a8a5086416f3RxCUI 208660, 314238UNII N0A3Z5XTC6UPC 0300650355032
- Pharmacologic class
- Anticholinergic
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
N400065035503followed by a unit qualifier and the quantityPackage 00065-0355-03. 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 mydriasis and cycloplegia for diagnostic procedures.
Excerpt only. Read the full label for complete information.
About NDC 0065-0355
- What is NDC 0065-0355?
- 0065-0355 is the product NDC for Mydriacyl (tropicamide), Tropicamide 10 mg/mL solution/ drops, listed with the FDA by Alcon Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mydriacyl (Tropicamide).
- What is the active ingredient?
- Tropicamide.
- 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 Mydriacyl?
- 1 other product NDC are listed under this name. See all Mydriacyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mydriacyl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mydriacyltropicamide | Tropicamide 10 mg/mL | Solution/ dropsOphthalmic | Alcon Laboratories, Inc. | 0998-0355 | 00998-0355-15 |
Other NDCs under ANDA 084306
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 |
|---|---|---|---|---|
| Mydriacyltropicamide | Tropicamide 10 mg/mL | Solution/ dropsOphthalmic | Alcon Laboratories, Inc. | 0998-0355 |
| Tropicamide | Tropicamide 10 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc | 61314-355 |