oxybutynin chloride
- Product NDC
- 16729-319
- 11-digit product format
- 167290319
- Labeler code
- 16729
- Product ID
- 16729-319_461437aa-cf86-2475-e063-6294a90afe5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxybutynin chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA207138
- Marketing category
- ANDA
- Marketing start
- 2016-12-14
- Substance
- OXYBUTYNIN CHLORIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- oxybutynin chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYBUTYNIN CHLORIDE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L9F3D9RENQ |
| Rxcui | 863619, 863628, 863636 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-319-01 | oxybutynin chloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 13 |
| 16729-319-10 | oxybutynin chloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 13 |
| 16729-319-16 | oxybutynin chloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 13 |
| 16729-319-17 | oxybutynin chloride | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-319 | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240328_61496a1e-17bf-4f45-a20c-5bb98fe545ee.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-319-01 | 16729031901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-319-01) | 2016-12-14 | 0000-00-00 | No | No | Current |
| 16729-319-10 | 16729031910 | 30 in 1 BOTTLE | | | | | Historical |
| 16729-319-16 | 16729031916 | 500 in 1 BOTTLE | | | | | Historical |
| 16729-319-17 | 16729031917 | 1000 in 1 BOTTLE | | | | | Historical |