OXYBUTYNIN CHLORIDE
- Product NDC
- 64980-679
- 11-digit product format
- 649800679
- Labeler code
- 64980
- Product ID
- 64980-679_9578b6b8-5b9d-4263-9142-39b2c7216b85
- 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
- 2026-04-27
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OXYBUTYNIN CHLORIDE
- Listing expiration
- 2027-12-31
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 |
|---|
| 64980-679-01 | OXYBUTYNIN CHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 64980-679-10 | OXYBUTYNIN CHLORIDE | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
| 64980-679-50 | OXYBUTYNIN CHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64980-679-01 | 64980067901 | 100 TABLET in 1 BOTTLE (64980-679-01) | 100 tablet | 2026-04-27 | No | No | Current |
| 64980-679-10 | 64980067910 | 1000 TABLET in 1 BOTTLE (64980-679-10) | 1000 tablet | 2026-04-27 | No | No | Current |
| 64980-679-50 | 64980067950 | 500 TABLET in 1 BOTTLE (64980-679-50) | 500 tablet | 2026-04-27 | No | No | Current |