Prescription drug · ANDA
Tolterodine tartrate NDC 33342-097
Tolterodine tartrate 1 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-097-09 | 3334200970933342009709 | 60 TABLET, FILM COATED in 1 BOTTLE (33342-097-09)Marketed from Oct 8, 2020 | |
| 33342-097-12 | 3334200971233342009712 | 10 BLISTER PACK in 1 CARTON (33342-097-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 8, 2020 | |
| 33342-097-15 | 3334200971533342009715 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-097-15)Marketed from Oct 8, 2020 |
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 tartrate
- Active ingredients
- Tolterodine tartrate — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203409
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 33342-097_fa641ff6-005b-47c5-bade-8709129d7ac9SPL ID fa641ff6-005b-47c5-bade-8709129d7ac9SPL set ID 3f2291c3-7e3c-41be-afa6-ef73ce896e30RxCUI 855178, 855194UNII 5T619TQR3RUPC 0333342097095
- 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
N433342009709followed by a unit qualifier and the quantityPackage 33342-0097-09. 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)
INDICATIONS & USAGE Tolterodine tartrate 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 33342-097
- What is NDC 33342-097?
- 33342-097 is the product NDC for Tolterodine tartrate, Tolterodine tartrate 1 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tolterodine tartrate.
- What is the active ingredient?
- Tolterodine tartrate.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-239 | 29300-0239-0529300-0239-16 |
Other NDCs under ANDA 203409
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 tartrate | Tolterodine tartrate 2 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-098 |