oxybutynin chloride
- Product NDC
- 72789-049
- 11-digit product format
- 727890049
- Labeler code
- 72789
- Product ID
- 72789-049_4af5faa0-1358-7489-e063-6294a90aae4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxybutynin chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA207138
- Marketing category
- ANDA
- Marketing start
- 2016-12-20
- Substance
- OXYBUTYNIN CHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L9F3D9RENQ |
| Rxcui | 863619 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-049-90 | oxybutynin chloride | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-049 | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240719_a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72789-049-90 | 72789004990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-049-90) | 2020-01-28 | 0000-00-00 | No | No | Current |