Prescription drug · ANDA
oxybutynin NDC 70771-1088
Oxybutynin chloride 15 mg/1 · Tablet, Film coated, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1088-1 | 70771108801 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1088-1)Marketed from Aug 10, 2017 | |
| 70771-1088-3 | 70771108803 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1088-3)Marketed from Aug 10, 2017 | |
| 70771-1088-4 | 70771108804 | 10 BLISTER PACK in 1 CARTON (70771-1088-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1088-2)Marketed from Aug 10, 2017 | |
| 70771-1088-5 | 70771108805 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1088-5)Marketed from Aug 10, 2017 | |
| 70771-1088-6 | 70771108806 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1088-6)Marketed from Aug 10, 2017 | |
| 70771-1088-9 | 70771108809 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1088-9)Marketed from Aug 10, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- oxybutynin
- Generic name (nonproprietary)
- oxybutynin
- Active ingredients
- Oxybutynin chloride — 15 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202332
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 70771-1088_e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0SPL ID e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0SPL set ID f405a774-bd91-4513-b7c7-c44f0596d988RxCUI 863619, 863628, 863636UNII L9F3D9RENQUPC 0368382256010
- 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
N470771108801followed by a unit qualifier and the quantityPackage 70771-1088-01. 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 .
Other NDCs under ANDA 202332
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 |
|---|---|---|---|---|
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-5353 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1087 |
| oxybutynin | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 70771-1086 |
| oxybutynin | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8219 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8220 |
| oxybutynin | Oxybutynin chloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-256 |
| oxybutynin | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-255 |
| oxybutynin | Oxybutynin chloride 15 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-257 |
| oxybutynin | Oxybutynin chloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Redpharm Drug | 67296-2335 |