Prescription drug · ANDA
Tolterodine tartrate NDC 27241-192
Tolterodine tartrate 4 mg/1 · Capsule, Extended release · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-192-05 | 27241019205 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-05)Marketed from Jun 25, 2020 | |
| 27241-192-30 | 27241019230 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-30)Marketed from Jun 25, 2020 | |
| 27241-192-90 | 27241019290 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-90)Marketed from Jun 25, 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 — 4 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Ajanta Pharma USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213397
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 27241-192_cf018a04-660f-4119-898f-1877a5db8e7eSPL ID cf018a04-660f-4119-898f-1877a5db8e7eSPL set ID fcaca033-cd08-4b8c-9bad-7b6751faf2c9RxCUI 855182, 855189UNII 5T619TQR3RUPC 0327241192302, 0327241191305
- 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
N427241019205followed by a unit qualifier and the quantityPackage 27241-0192-05. 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 indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES ( 14)]. 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 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213397
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 | Capsule, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-191 |