Oxybutynin Chloride
- Product NDC
- 43353-322
- 11-digit product format
- 433530322
- Labeler code
- 43353
- Product ID
- 43353-322_a9056bad-e15c-4be4-a63c-f51362e2f025
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078503
- Marketing category
- ANDA
- Marketing start
- 2016-03-09
- Substance
- OXYBUTYNIN CHLORIDE
- Active strength
- 15 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
- Brand name suffix
- Extended Release
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYBUTYNIN CHLORIDE | 15 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | L9F3D9RENQ |
| Rxcui | 863619, 863628, 863636 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| 3544f362-07fc-93b1-457b-1fba00be087a | Product name | 8 | 20230316 |
| 4daffbf2-44c8-ca46-d284-5db69e1e6ef4 | Product name | 8 | 20210525 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 982338c6-c45c-b6b4-1452-14b01fbdf98d | Product name | 2 | 20180801 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 054197ba-7ed3-0ddb-321e-dbb51c0fe9b6 | Product name | 2 | 20171212 |
| 3544f362-07fc-93b1-457b-1fba00be087a | Product name | 2 | 20171212 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 8b00ae7e-01f2-f83c-632e-edfc23808364 | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43353-322-16 | Oxybutynin ChlorideExtended Release | 6000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 6000 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-322-16 | EA - Each | 43353-322 | 89462f76-5e41-4add-a1e3-a45a5c725bfc | 1 | 2017-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43353-322 | OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230602_02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 863619 | oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet | PSN | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
| 863628 | oxyBUTYnin chloride 15 MG 24HR Extended Release Oral Tablet | PSN | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
| 863636 | oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet | PSN | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
| 863619 | 24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet | SCD | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
| 863628 | 24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet | SCD | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
| 863636 | 24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet | SCD | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
| 863619 | oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet | SY | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
| 863628 | oxybutynin chloride 15 MG 24 HR Extended Release Oral Tablet | SY | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
| 863636 | oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet | SY | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43353-322-16 | 43353032216 | 6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-322-16) | 2017-05-11 | 0000-00-00 | No | No | Current |