Ditropan
- Product NDC
- 50458-810
- 11-digit product format
- 504580810
- Labeler code
- 50458
- Product ID
- 50458-810_f0492e82-8867-4fe5-e053-2995a90a2a22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxybutynin chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA020897
- Marketing category
- NDA
- Marketing start
- 1999-06-26
- Marketing end
- 2023-09-30
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| oxybutynin chloride | ACTIVE INGREDIENT | L9F3D9RENQ | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| oxybutynin | ACTIVE MOIETY | K9P6MC7092 | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| butylated hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| cellulose acetate | INACTIVE INGREDIENT | 3J2P07GVB6 | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DITROPAN XL (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
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 |
|---|
| 50458-810-01 | 50458081001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-810-01) | 1999-06-26 | 0000-00-00 | No | No | Current |