Oxybutynin Chloride
- Product NDC
- 43353-978
- 11-digit product format
- 433530978
- Labeler code
- 43353
- Product ID
- 43353-978_c8f0373d-45aa-49dc-8436-4fc1a9304a57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA074625
- Marketing category
- ANDA
- Marketing start
- 2011-11-07
- 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
- 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 | 863664 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-978-92 | Oxybutynin Chloride | 270 in 1 BOTTLE | TABLET | 270 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-978 | OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20160708_58136f28-70c1-4cf2-bcd7-858c5609431a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-978-92 | 43353097892 | 270 TABLET in 1 BOTTLE (43353-978-92) | 270 tablet | 2014-11-01 | 0000-00-00 | No | No | Current |