OXYBUTYNIN CHLORIDE
- Product NDC
- 64980-531
- 11-digit product format
- 649800531
- Labeler code
- 64980
- Product ID
- 64980-531_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
- 2023-04-01
- Substance
- OXYBUTYNIN CHLORIDE
- Active strength
- 2.5 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 | 2.5 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 |
|---|
| 64980-531-01 | OXYBUTYNIN CHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-531 | OXYBUTYNIN CHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] | 8 | Current NDC, 1 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 | Sample | Exclude flag | Status |
|---|
| 64980-531-01 | 64980053101 | 100 TABLET in 1 BOTTLE (64980-531-01) | 100 tablet | 2023-04-01 | No | No | Current |