Prescription drug · ANDA
Tolterodine Tartrate (Tolterodine) NDC 13668-189
Tolterodine tartrate 2 mg/1 · Capsule, Extended release · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-189-05 | 1366801890513668018905 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-05)Marketed from Aug 11, 2015 | |
| 13668-189-30 | 1366801893013668018930 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-30)Marketed from Aug 11, 2015 | |
| 13668-189-74 | 1366801897413668018974 | 100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-189-74)Marketed from Aug 11, 2015 | |
| 13668-189-90 | 1366801899013668018990 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-90)Marketed from Aug 11, 2015 |
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)
- Tolterodine Tartrate
- Generic name (nonproprietary)
- tolterodine
- Active ingredients
- Tolterodine tartrate — 2 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203016
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 13668-189_de456fdd-b0a2-4b65-b926-bb9948fde276SPL ID de456fdd-b0a2-4b65-b926-bb9948fde276SPL set ID db6e0b6d-0ce5-41d7-881f-881c11f530a4RxCUI 855182, 855189UNII 5T619TQR3RUPC 0313668189308, 0313668190304
- 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
N413668018905followed by a unit qualifier and the quantityPackage 13668-0189-05. 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)
Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 ) Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [ see CLINICAL STUDIES ( 14 ) ].
Excerpt only. Read the full label for complete information.
About NDC 13668-189
- What is NDC 13668-189?
- 13668-189 is the product NDC for Tolterodine Tartrate (tolterodine), Tolterodine tartrate 2 mg/1 capsule, extended release, listed with the FDA by Torrent Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tolterodine Tartrate (Tolterodine).
- What is the active ingredient?
- Tolterodine tartrate.
- Who is the labeler?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tolterodine Tartrate?
- 31 other product NDCs are listed under this name. See all Tolterodine Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tolterodine Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tolterodine Tartrate | Tolterodine tartrate 2 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7574 | 00904-7574-04 |
| Tolterodine Tartrate | Tolterodine tartrate 4 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7575 | 00904-7575-04 |
| Tolterodine tartrate | Tolterodine tartrate 4 mg/1 | Capsule, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-307 | 29300-0307-0529300-0307-1329300-0307-19 |
| Tolterodine tartrate | Tolterodine tartrate 2 mg/1 | Capsule, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-306 | 29300-0306-0529300-0306-1329300-0306-19 |
| Tolterodine Tartrate | Tolterodine tartrate 2 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-806 | 31722-0806-0131722-0806-0231722-0806-05+1 more |
| Tolterodine Tartrate | Tolterodine tartrate 1 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-805 | 31722-0805-0131722-0805-0231722-0805-05+1 more |
| Tolterodine Tartrate | Tolterodine tartrate 2 mg/1 | Capsule, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-160 | 70436-0160-0270436-0160-0470436-0160-06 |
| Tolterodine Tartrate | Tolterodine tartrate 4 mg/1 | Capsule, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-161 | 70436-0161-0270436-0161-0470436-0161-06 |
| Tolterodine tartrate | Tolterodine tartrate 2 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-098 | 33342-0098-0933342-0098-1233342-0098-15 |
| Tolterodine tartrate | Tolterodine tartrate 1 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-097 | 33342-0097-0933342-0097-1233342-0097-15 |
Other NDCs under ANDA 203016
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 |
|---|---|---|---|---|
| Tolterodine Tartratetolterodine | Tolterodine tartrate 4 mg/1 | Capsule, Extended releaseOral | Torrent Pharmaceuticals Limited | 13668-190 |
| Tolterodine Tartratetolterodine | Tolterodine tartrate 2 mg/1 | Capsule, Extended releaseOral | American Health Packaging | 60687-319 |
| Tolterodine Tartratetolterodine | Tolterodine tartrate 4 mg/1 | Capsule, Extended releaseOral | American Health Packaging | 60687-330 |