Prescription drug · ANDA
Tolterodine Tartrate NDC 71205-319
Tolterodine tartrate 1 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-319-30 | 71205031930 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-319-30)Marketed from Sep 1, 2019 | |
| 71205-319-60 | 71205031960 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-319-60)Marketed from Sep 1, 2019 | |
| 71205-319-90 | 71205031990 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-319-90)Marketed from Sep 1, 2019 |
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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077006
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 71205-319_df5371c1-a1d3-4e6d-af7a-17cb46d7653dSPL ID df5371c1-a1d3-4e6d-af7a-17cb46d7653dSPL set ID b77f9893-a422-423a-bb27-527377ade36dRxCUI 855178UNII 5T619TQR3R
- 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
N471205031930followed by a unit qualifier and the quantityPackage 71205-0319-30. 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 AND USAGE Tolterodine 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.
Other NDCs under ANDA 077006
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 1 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0010 |
| Tolterodine Tartrate | Tolterodine tartrate 2 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0018 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.