oxybutynin
- Product NDC
- 0615-8219
- 11-digit product format
- 006158219
- Labeler code
- 0615
- Product ID
- 0615-8219_7a51ea21-3f85-4693-8e7e-ed031f257496
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxybutynin
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA202332
- Marketing category
- ANDA
- Marketing start
- 2017-08-10
- Substance
- OXYBUTYNIN CHLORIDE
- Active strength
- 5 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYBUTYNIN CHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L9F3D9RENQ |
| Rxcui | 863636 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8219-39 | oxybutynin | 30 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8219 | OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240817_ed10f0c9-23d6-4ded-b17f-ed474632a965.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 |
|---|
| 0615-8219-39 | 00615821939 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8219-39) | 2019-01-25 | 0000-00-00 | No | No | Current |