Oxybutynin Chloride
- Product NDC
- 64380-162
- 11-digit product format
- 643800162
- Labeler code
- 64380
- Product ID
- 64380-162_289e5f8b-6604-47a3-a3af-e2309972ba7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxybutynin chloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA075079
- Marketing category
- ANDA
- Marketing start
- 2022-04-04
- 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, 863758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-162-01 | Oxybutynin Chloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 6 |
| 64380-162-02 | Oxybutynin Chloride | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 6 |
| 64380-162-03 | Oxybutynin Chloride | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-162 | OXYBUTYNIN CHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20220404_9ede5def-d185-4e40-9c10-8663ac654caf.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 |
|---|
| 64380-162-01 | 64380016201 | 100 TABLET in 1 BOTTLE, PLASTIC (64380-162-01) | 100 tablet | 2022-09-30 | 0000-00-00 | No | No | Current |
| 64380-162-02 | 64380016202 | 500 TABLET in 1 BOTTLE, PLASTIC (64380-162-02) | 500 tablet | 2022-04-04 | 0000-00-00 | No | No | Current |
| 64380-162-03 | 64380016203 | 1000 TABLET in 1 BOTTLE, PLASTIC (64380-162-03) | 1000 tablet | 2022-09-30 | 0000-00-00 | No | No | Current |