Prescription drug · ANDA
Darifenacin NDC 33342-277
Darifenacin hydrobromide 15 mg/1 · Tablet, Extended release · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-277-07 | 33342027707 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-07)Marketed from Jul 29, 2017 | |
| 33342-277-10 | 33342027710 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-10)Marketed from Jul 29, 2017 | |
| 33342-277-12 | 33342027712 | 10 BLISTER PACK in 1 CARTON (33342-277-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 29, 2017 |
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)
- Darifenacin
- Generic name (nonproprietary)
- darifenacin
- Active ingredients
- Darifenacin hydrobromide — 15 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207302
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 33342-277_2abbe156-e5ab-484c-aed7-fa4b5f06698dSPL ID 2abbe156-e5ab-484c-aed7-fa4b5f06698dSPL set ID 7ae60119-e22c-4806-a5d8-db7c9e8984a2RxCUI 485421, 485423UNII CR02EYQ8GVUPC 0333342277077, 0333342276070, 0333342277107, 0333342276100
- Pharmacologic class
- Cholinergic Muscarinic Antagonist
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N433342027707followed by a unit qualifier and the quantityPackage 33342-0277-07. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.