OXYBUTYNIN CHLORIDE
- Product NDC
- 64980-431
- 11-digit product format
- 649800431
- Labeler code
- 64980
- Product ID
- 64980-431_92fdb885-c818-4c39-909a-7f2f53840d90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYBUTYNIN CHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RISING PHARMA HOLDINGS, INC.
- Application
- ANDA209025
- Marketing category
- ANDA
- Marketing start
- 2018-02-01
- 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
- 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, 863758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64980-431-01 | OXYBUTYNIN CHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 64980-431-10 | OXYBUTYNIN CHLORIDE | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
| 64980-431-50 | OXYBUTYNIN CHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-431 | OXYBUTYNIN CHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240704_f8ed80f2-6c3d-4d7f-b761-c2447973c1f9.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 |
|---|
| 64980-431-01 | 64980043101 | 100 TABLET in 1 BOTTLE (64980-431-01) | 100 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |
| 64980-431-10 | 64980043110 | 1000 TABLET in 1 BOTTLE (64980-431-10) | 1000 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |
| 64980-431-50 | 64980043150 | 500 TABLET in 1 BOTTLE (64980-431-50) | 500 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |