Oxybutynin Chloride
- Product NDC
- 65162-372
- 11-digit product format
- 651620372
- Labeler code
- 65162
- Product ID
- 65162-372_25b959bc-5b59-4c9c-b7a0-ae475a8e0290
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA204010
- Marketing category
- ANDA
- Marketing start
- 2015-11-02
- 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
- 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 | 10 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 |
|---|
| 65162-372-03 | Oxybutynin Chloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 19 |
| 65162-372-09 | Oxybutynin Chloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 19 |
| 65162-372-10 | Oxybutynin Chloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 19 |
| 65162-372-50 | Oxybutynin Chloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXYBUTYNIN CHLORIDE | ACTIVE INGREDIENT | L9F3D9RENQ | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| OXYBUTYNIN | ACTIVE MOIETY | K9P6MC7092 | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-372 | OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 19 | Current NDC, Legacy NDC, 4 package rows | 20241031_53924eba-1919-4203-9a1e-d57dfdd3b963.zip |
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 |
|---|
| 65162-372-03 | 65162037203 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-372-03) | 2015-11-02 | 0000-00-00 | No | No | Current |
| 65162-372-09 | 65162037209 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-372-09) | 2015-11-02 | 0000-00-00 | No | No | Current |
| 65162-372-10 | 65162037210 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-372-10) | 2015-11-02 | 0000-00-00 | No | No | Current |
| 65162-372-50 | 65162037250 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-372-50) | 2015-11-02 | 0000-00-00 | No | No | Current |