Oxybutynin Chloride
- Product NDC
- 50090-4192
- 11-digit product format
- 500904192
- Labeler code
- 50090
- Product ID
- 50090-4192_d45fa36a-39f1-4125-8b3c-38aed44b3887
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078503
- Marketing category
- ANDA
- Marketing start
- 2009-03-01
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4192-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2609-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS. OXYBUTYNIN CHLORIDE extended-release tablets, USP, for oral use Initial U.S. Approval: 1975 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4192-0 | Oxybutynin ChlorideExtended Release | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4192 | OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 6 | Legacy NDC, 1 package rows | 20210617_9b875869-2fe6-4274-bb1a-3a1406616ce7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 863636 | oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet | PSN | 9b875869-2fe6-4274-bb1a-3a1406616ce7 | 6 |
| 863636 | 24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet | SCD | 9b875869-2fe6-4274-bb1a-3a1406616ce7 | 6 |
| 863636 | oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet | SY | 9b875869-2fe6-4274-bb1a-3a1406616ce7 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-4192-0 | 50090419200 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4192-0) | 2019-03-15 | 0000-00-00 | No | No | Current |