Oxybutynin Chloride
- Product NDC
- 43353-285
- 11-digit product format
- 433530285
- Labeler code
- 43353
- Product ID
- 43353-285_9eda2c93-de21-45ec-a9dc-1329d6d44be7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078503
- Marketing category
- ANDA
- Marketing start
- 2009-03-01
- 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 Chloride
- Brand name suffix
- Extended Release
- 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 |
|---|
| 43353-285-30 | Oxybutynin ChlorideExtended Release | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 43353-285-53 | Oxybutynin ChlorideExtended Release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 1 |
| 43353-285-60 | Oxybutynin ChlorideExtended Release | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-285 | OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20171021_e985e201-2fb3-4781-9790-a1a3db1ae2a1.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 |
|---|
| 43353-285-30 | 43353028530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-285-30) | 2017-03-02 | 0000-00-00 | No | No | Current |
| 43353-285-53 | 43353028553 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-285-53) | 2017-03-02 | 0000-00-00 | No | No | Current |
| 43353-285-60 | 43353028560 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-285-60) | 2017-03-02 | 0000-00-00 | No | No | Current |