Prescription drug · ANDA
fesoterodine fumarate NDC 70771-1169
Fesoterodine fumarate 8 mg/1 · Tablet, Film coated, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1169-3 | 7077111690370771116903 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1169-3)Marketed from Dec 7, 2017 | |
| 70771-1169-4 | 7077111690470771116904 | 10 BLISTER PACK in 1 CARTON (70771-1169-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1169-2)Marketed from Dec 7, 2017 | |
| 70771-1169-9 | 7077111690970771116909 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1169-9)Marketed from Dec 7, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- fesoterodine fumarate
- Generic name (nonproprietary)
- fesoterodine fumarate
- Active ingredients
- Fesoterodine fumarate — 8 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204946
- Marketing start
- Listing expires
- Identifiers
- Product ID 70771-1169_5b9a792a-f173-43f9-917a-af99185196e1SPL ID 5b9a792a-f173-43f9-917a-af99185196e1SPL set ID 26e8cc63-1e1d-4a77-8f53-4c38bcf0d443RxCUI 810071, 810077UNII EOS72165S7
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
N470771116903followed by a unit qualifier and the quantityPackage 70771-1169-03. 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 .
About NDC 70771-1169
- What is NDC 70771-1169?
- 70771-1169 is the product NDC for fesoterodine fumarate, Fesoterodine fumarate 8 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- fesoterodine fumarate.
- What is the active ingredient?
- Fesoterodine fumarate.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for fesoterodine fumarate?
- 21 other product NDCs are listed under this name. See all fesoterodine fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other fesoterodine fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 72603-413 | 72603-0413-01 |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 72603-414 | 72603-0414-01 |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-033 | 31722-0033-3031722-0033-90 |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-034 | 31722-0034-3031722-0034-90 |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-175 | 46708-0175-1046708-0175-3046708-0175-90+1 more |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-176 | 46708-0176-1046708-0176-3046708-0176-90+1 more |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-175 | 62332-0175-1062332-0175-3062332-0175-90+1 more |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-176 | 62332-0176-1062332-0176-3062332-0176-90+1 more |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-369 | 65162-0369-0365162-0369-09 |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-370 | 65162-0370-0365162-0370-09 |
Other NDCs under ANDA 204946
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 |
|---|---|---|---|---|
| fesoterodine fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-479 |
| fesoterodine fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-480 |
| fesoterodine fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1168 |