oxybutynin
- Product NDC
- 68382-255
- 11-digit product format
- 683820255
- Labeler code
- 68382
- Product ID
- 68382-255_f54e4d4e-91be-4e10-a446-57ed5e1843a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxybutynin
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA202332
- Marketing category
- ANDA
- Marketing start
- 2017-08-10
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- oxybutynin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYBUTYNIN CHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L9F3D9RENQ |
| Rxcui | 863619, 863628, 863636 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-255-01 | oxybutynin | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 7 |
| 68382-255-05 | oxybutynin | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 7 |
| 68382-255-06 | oxybutynin | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 7 |
| 68382-255-14 | oxybutynin | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 7 |
| 68382-255-16 | oxybutynin | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 7 |
| 68382-255-30 | oxybutynin | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 7 |
| 68382-255-77 | oxybutynin | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-255 | OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 7 package rows | 20231110_c042bf06-79a3-4dc7-ae05-3ef3cfae9d44.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 |
|---|
| 68382-255-01 | 68382025501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-01) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 68382-255-05 | 68382025505 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-05) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 68382-255-06 | 68382025506 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-06) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 68382-255-14 | 68382025514 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-14) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 68382-255-16 | 68382025516 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-16) | | 2017-08-10 | 0000-00-00 | No | No | Current |
| 68382-255-30 | 68382025530 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-255-77 | 68382025577 | 10 BLISTER PACK in 1 CARTON (68382-255-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-255-30) | 10 blister pack | 2017-08-10 | 0000-00-00 | No | No | Current |