OXYBUTYNIN CHLORIDE
- Product NDC
- 0615-8492
- 11-digit product format
- 006158492
- Labeler code
- 0615
- Product ID
- 0615-8492_126741bf-877c-4f91-a0e0-a2378747e33b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYBUTYNIN CHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA212798
- Marketing category
- ANDA
- Marketing start
- 2019-11-01
- 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 CHLORIDE
- 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 | 863664 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8492-05 | OXYBUTYNIN CHLORIDE | 15 in 1 BLISTER PACK | TABLET | 15 | | 1 |
| 0615-8492-39 | OXYBUTYNIN CHLORIDE | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8492 | OXYBUTYNIN CHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 2 package rows | 20231005_5b72d34e-ae57-4459-ba2c-3bae8a69c5c1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8492-05 | 00615849205 | 15 TABLET in 1 BLISTER PACK (0615-8492-05) | 15 tablet | 2023-10-03 | No | No | Current |
| 0615-8492-39 | 00615849239 | 30 TABLET in 1 BLISTER PACK (0615-8492-39) | 30 tablet | 2023-10-03 | No | No | Current |