Prescription drug · ANDA
Oxybutynin Chloride NDC 70954-005
Oxybutynin chloride 5 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-005-10 | 7095400051070954000510 | 100 TABLET in 1 BOTTLE (70954-005-10)Marketed from Nov 15, 2017 | |
| 70954-005-20 | 7095400052070954000520 | 500 TABLET in 1 BOTTLE (70954-005-20)Marketed from Nov 15, 2017 | |
| 70954-005-30 | 7095400053070954000530 | 1000 TABLET in 1 BOTTLE (70954-005-30)Marketed from Nov 15, 2017 | |
| 70954-005-50 | 7095400055070954000550 | 100 BLISTER PACK in 1 CARTON (70954-005-50) / 1 TABLET in 1 BLISTER PACK (70954-005-40)Marketed from Aug 20, 2021 |
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)
- Oxybutynin Chloride
- Generic name (nonproprietary)
- oxybutynin chloride
- Active ingredients
- Oxybutynin chloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209823
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 70954-005_db0e9137-4243-4f35-87fb-19668c1bd480SPL ID db0e9137-4243-4f35-87fb-19668c1bd480SPL set ID 3b1f5585-9b33-4a96-bf33-8e6bab14bf0cRxCUI 863664UNII L9F3D9RENQUPC 0370954005308, 0370954005100, 0370954005209
- 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
N470954000510followed by a unit qualifier and the quantityPackage 70954-0005-10. 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 Oxybutynin chloride tablets, USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
Excerpt only. Read the full label for complete information.
About NDC 70954-005
- What is NDC 70954-005?
- 70954-005 is the product NDC for Oxybutynin Chloride, Oxybutynin chloride 5 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxybutynin Chloride.
- What is the active ingredient?
- Oxybutynin chloride.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxybutynin Chloride?
- 79 other product NDCs are listed under this name. See all Oxybutynin Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxybutynin Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxybutynin Chloride | Oxybutynin chloride 2.5 mg/1 | TabletOral | TruPharma LLC | 52817-261 | 52817-0261-10 |
| Oxybutynin Chloride | Oxybutynin chloride 2.5 mg/1 | TabletOral | RISING PHARMA HOLDINGS, INC. | 64980-734 | 64980-0734-01 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Coupler LLC | 67046-1381 | 67046-1381-03 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-913 | 23155-0913-0123155-0913-0523155-0913-10 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | RISING PHARMA HOLDINGS, INC. | 64980-679 | 64980-0679-0164980-0679-1064980-0679-50 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-8078 | 50090-8078-0050090-8078-0150090-8078-03 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | American Health Packaging | 60687-899 | 60687-0899-01 |
| Oxybutynin Chloride | Oxybutynin chloride 2.5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-190 | 64380-0190-01 |
| Oxybutynin Chloride | Oxybutynin chloride 15 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1600 | 67046-1600-03 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1599 | 67046-1599-03 |
Other NDCs under ANDA 209823
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 Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7027 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6966 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6967 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-099 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-665 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2632 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-642 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-277 |
| Oxybutynin Chloride | Oxybutynin chloride 5 mg/1 | TabletOral | VERITYRX, LLC | 83939-0022 |