Prescription drug · ANDA
Darifenacin NDC 16571-768
Darifenacin hydrobromide 15 mg/1 · Tablet, Film coated, Extended release · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-768-03 | 1657107680316571076803 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-03)Marketed from Sep 19, 2016 | |
| 16571-768-09 | 1657107680916571076809 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-09)Marketed from Sep 19, 2016 |
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, Film coated, Extended release
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206743
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 16571-768_fd55c56a-79a8-4830-92d7-19f62bee0b5fSPL ID fd55c56a-79a8-4830-92d7-19f62bee0b5fSPL set ID e2aa9544-0136-463d-a73b-1a299534446aRxCUI 485421, 485423UNII CR02EYQ8GVUPC 0316571767038
- 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
N416571076803followed by a unit qualifier and the quantityPackage 16571-0768-03. 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)
Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 16571-768
- What is NDC 16571-768?
- 16571-768 is the product NDC for Darifenacin, Darifenacin hydrobromide 15 mg/1 tablet, film coated, extended release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Darifenacin.
- What is the active ingredient?
- Darifenacin hydrobromide.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Darifenacin?
- 15 other product NDCs are listed under this name. See all Darifenacin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Darifenacin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Darifenacin | Darifenacin hydrobromide 7.5 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-223 | 46708-0223-0846708-0223-3046708-0223-90+1 more |
| Darifenacin | Darifenacin hydrobromide 15 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-224 | 46708-0224-0846708-0224-3046708-0224-90+1 more |
| Darifenacin | Darifenacin hydrobromide 7.5 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-223 | 62332-0223-0862332-0223-3062332-0223-90+1 more |
| Darifenacin | Darifenacin hydrobromide 15 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-224 | 62332-0224-0862332-0224-3062332-0224-90+1 more |
| Darifenacin | Darifenacin hydrobromide 7.5 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-276 | 33342-0276-0733342-0276-1033342-0276-12 |
| Darifenacin | Darifenacin hydrobromide 15 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-277 | 33342-0277-0733342-0277-1033342-0277-12 |
| Darifenacin | Darifenacin hydrobromide 7.5 mg/1 | Tablet, Extended releaseOral | Torrent Pharmaceuticals Limited | 13668-202 | 13668-0202-0513668-0202-3013668-0202-90 |
| Darifenacin | Darifenacin hydrobromide 15 mg/1 | Tablet, Extended releaseOral | Torrent Pharmaceuticals Limited | 13668-203 | 13668-0203-0513668-0203-3013668-0203-90 |
| Darifenacin | Darifenacin hydrobromide 7.5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2570 | 72162-2570-03 |
| Darifenacin | Darifenacin hydrobromide 15 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2571 | 72162-2571-03 |
Other NDCs under ANDA 206743
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 |
|---|---|---|---|---|
| Darifenacin | Darifenacin hydrobromide 7.5 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-767 |
| Darifenacin | Darifenacin hydrobromide 7.5 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-861 |
| Darifenacin | Darifenacin hydrobromide 15 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-862 |