Oxybutynin Chloride
- Product NDC
- 10135-609
- 11-digit product format
- 101350609
- Labeler code
- 10135
- Product ID
- 10135-609_da063b55-10e9-4231-9f23-22216f257455
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA204010
- Marketing category
- ANDA
- Marketing start
- 2016-02-01
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-609-01 | Oxybutynin Chloride | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 10135-609-05 | Oxybutynin Chloride | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-609 | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC] | 3 | Legacy NDC, 2 package rows | 20191213_301a7fca-c556-4b53-899f-bc7e2a74ded8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10135-609-01 | 10135060901 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 10135-609-05 | 10135060905 | 500 in 1 BOTTLE, PLASTIC | Historical |