Prescription drug · ANDA
Darifenacin (Darifenacin hydrobromide) NDC 69097-431
Darifenacin hydrobromide 7.5 mg/1 · Tablet, Extended release · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-431-02 | 6909704310269097043102 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-02)Marketed from Sep 1, 2016 | |
| 69097-431-05 | 6909704310569097043105 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-05)Marketed from Sep 1, 2016 | |
| 69097-431-15 | 6909704311569097043115 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-15)Marketed from Sep 1, 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 hydrobromide
- Active ingredients
- Darifenacin hydrobromide — 7.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207664
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 69097-431_99ca2704-b757-4f10-be5c-bd01dff69b10SPL ID 99ca2704-b757-4f10-be5c-bd01dff69b10SPL set ID 6e8470d1-c3e6-4644-b70a-aa47ddf79676RxCUI 485421, 485423UNII CR02EYQ8GV
- 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
N469097043102followed by a unit qualifier and the quantityPackage 69097-0431-02. 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)
Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ( 1 ) Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Excerpt only. Read the full label for complete information.
About NDC 69097-431
- What is NDC 69097-431?
- 69097-431 is the product NDC for Darifenacin (darifenacin hydrobromide), Darifenacin hydrobromide 7.5 mg/1 tablet, extended release, listed with the FDA by Cipla USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Darifenacin (Darifenacin Hydrobromide).
- What is the active ingredient?
- Darifenacin hydrobromide.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. 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 207664
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 |
|---|---|---|---|---|
| Darifenacindarifenacin hydrobromide | Darifenacin hydrobromide 15 mg/1 | Tablet, Extended releaseOral | Cipla USA Inc. | 69097-432 |