Oxybutynin Chloride
- Product NDC
- 54838-510
- 11-digit product format
- 548380510
- Labeler code
- 54838
- Product ID
- 54838-510_693f3eb4-b7f1-420a-b813-ecd8e326882d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA074520
- Marketing category
- ANDA
- Marketing start
- 1996-03-29
- Substance
- OXYBUTYNIN CHLORIDE
- Active strength
- 5 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L9F3D9RENQ |
| Rxcui | 863599 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54838-510-80 | Oxybutynin Chloride | 473 mL in 1 BOTTLE, PLASTIC | SYRUP | 473 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Oxybutynin Chloride | ACTIVE INGREDIENT | L9F3D9RENQ | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| Oxybutynin | ACTIVE MOIETY | K9P6MC7092 | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| FD&C Green No. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | OXYBUTYNIN CHLORIDE SYRUP [SILARX PHARMACEUTICALS, INC] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54838-510 | OXYBUTYNIN CHLORIDE SYRUP [LANNETT COMPANY, INC.] | 24 | Current NDC, Legacy NDC, 1 package rows | 20250406_615f3d95-197c-4fec-b81f-c26449c93c3b.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 |
|---|
| 54838-510-80 | 54838051080 | 473 mL in 1 BOTTLE, PLASTIC (54838-510-80) | 473 ml | 1996-03-29 | 0000-00-00 | No | No | Current |