Prescription drug · ANDA
Tolterodine Tartrate NDC 43975-323
Tolterodine tartrate 4 mg/1 · Capsule, Extended release · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43975-323-03 | 43975032303 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-03)Marketed from Aug 29, 2019 | |
| 43975-323-09 | 43975032309 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-09)Marketed from Aug 29, 2019 | |
| 43975-323-50 | 43975032350 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-50)Marketed from Aug 29, 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 — 4 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204562
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 43975-323_361c4d47-0750-6f78-e063-6394a90ab0c0SPL ID 361c4d47-0750-6f78-e063-6394a90ab0c0SPL set ID fc5bdc4a-a483-4d31-807b-c7f8d8869723RxCUI 855182, 855189UNII 5T619TQR3RUPC 0343975323034, 0343975322037
- 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
N443975032303followed by a unit qualifier and the quantityPackage 43975-0323-03. 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 .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Tolterodine tartrate extended-release capsules, USP 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, USP 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 204562
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 | Major Pharmaceuticals | 0904-7574 |
| Tolterodine Tartrate | Tolterodine tartrate 4 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7575 |
| Tolterodine Tartrate | Tolterodine tartrate 4 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-740 |
| Tolterodine Tartrate | Tolterodine tartrate 2 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-739 |
| Tolterodine Tartrate | Tolterodine tartrate 2 mg/1 | Capsule, Extended releaseOral | ANI Pharmaceuticals, Inc. | 43975-322 |