Oxybutynin Chloride
- Product NDC
- 43353-282
- 11-digit product format
- 433530282
- Labeler code
- 43353
- Product ID
- 43353-282_a9056bad-e15c-4be4-a63c-f51362e2f025
- 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
- 2016-03-09
- 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 | 863619, 863628, 863636 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-282-30 | Oxybutynin ChlorideExtended Release | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 43353-282-53 | Oxybutynin ChlorideExtended Release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 2 |
| 43353-282-60 | Oxybutynin ChlorideExtended Release | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 2 |
| 43353-282-80 | Oxybutynin ChlorideExtended Release | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-282 | OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 4 package rows | 20230602_02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a.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 |
|---|
| 43353-282-30 | 43353028230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-30) | 2017-03-02 | 0000-00-00 | No | No | Current |
| 43353-282-53 | 43353028253 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-53) | 2017-03-02 | 0000-00-00 | No | No | Current |
| 43353-282-60 | 43353028260 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-60) | 2017-03-02 | 0000-00-00 | No | No | Current |
| 43353-282-80 | 43353028280 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-80) | 2023-05-31 | | No | No | Historical |