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NDC 43353-0322-16 Oxybutynin Chloride 15 mg/1 Details
Oxybutynin Chloride 15 mg/1
Oxybutynin Chloride is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is OXYBUTYNIN CHLORIDE.
MedlinePlus Drug Summary
Oxybutynin is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in certain adults and children. Oxybutynin is also used as an extended-release tablet to control bladder muscles in adults and children 6 years of age and older with spina bifida (a disability that occurs when the spinal cord does not close properly before birth), or other nervous system conditions that affect the bladder muscles. Oxybutynin is in a class of medications called anticholinergics/antimuscarinics. It works by relaxing the bladder muscles.
Related Packages: 43353-0322-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxybutynin
Product Information
| NDC | 43353-0322 |
|---|---|
| Product ID | 43353-322_a9056bad-e15c-4be4-a63c-f51362e2f025 |
| Associated GPIs | 54100045207540 |
| GCN Sequence Number | 042606 |
| GCN Sequence Number Description | oxybutynin chloride TAB ER 24 15 MG ORAL |
| HIC3 | R1A |
| HIC3 Description | URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT |
| GCN | 93557 |
| HICL Sequence Number | 002048 |
| HICL Sequence Number Description | OXYBUTYNIN CHLORIDE |
| Brand/Generic | Generic |
| Proprietary Name | Oxybutynin Chloride |
| Proprietary Name Suffix | Extended Release |
| Non-Proprietary Name | Oxybutynin Chloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/1 |
| Substance Name | OXYBUTYNIN CHLORIDE |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Pharmaceutical Class | Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078503 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43353-0322-16 (43353032216)
| NDC Package Code | 43353-322-16 |
|---|---|
| Billing NDC | 43353032216 |
| Package | 6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-322-16) |
| Marketing Start Date | 2017-05-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |