Oxybutynin Chloride
- Product NDC
- 70954-005
- 11-digit product format
- 709540005
- Labeler code
- 70954
- Product ID
- 70954-005_db0e9137-4243-4f35-87fb-19668c1bd480
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA209823
- Marketing category
- ANDA
- Marketing start
- 2017-11-15
- 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
- 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 |
|---|---|
| OXYBUTYNIN CHLORIDE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | L9F3D9RENQ |
| Rxcui | 863664 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3544f362-07fc-93b1-457b-1fba00be087a | Product name | 8 | 20230316 |
| 4daffbf2-44c8-ca46-d284-5db69e1e6ef4 | Product name | 8 | 20210525 |
| 982338c6-c45c-b6b4-1452-14b01fbdf98d | Product name | 2 | 20180801 |
| 054197ba-7ed3-0ddb-321e-dbb51c0fe9b6 | Product name | 2 | 20171212 |
| 3544f362-07fc-93b1-457b-1fba00be087a | Product name | 2 | 20171212 |
| 8b00ae7e-01f2-f83c-632e-edfc23808364 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70954-005-10 | Oxybutynin Chloride | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 70954-005-20 | Oxybutynin Chloride | 500 in 1 BOTTLE | TABLET | 500 | 4 | |
| 70954-005-30 | Oxybutynin Chloride | 1000 in 1 BOTTLE | TABLET | 1000 | 4 | |
| 70954-005-40 | Oxybutynin Chloride | 1 in 1 BLISTER PACK | TABLET | 1 | 4 | |
| 70954-005-50 | Oxybutynin Chloride | 100 in 1 CARTON | TABLET | 100 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70954-005-10 | EA - Each | 70954-005 | 578dfbca-9e3c-4f4d-942f-e7a4d331a0dd | 1 | 2018-01-12 |
| 70954-005-20 | EA - Each | 70954-005 | ca724434-4206-4756-9065-a38e6252df49 | 1 | 2018-01-12 |
| 70954-005-30 | EA - Each | 70954-005 | ad034756-247c-496f-a21a-aae5cc3291d8 | 1 | 2018-01-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | 6f409d7f-b064-1363-e053-2a91aa0a3a14 | 6 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | 6f409d7f-b064-1363-e053-2a91aa0a3a14 | 6 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | 3b1f5585-9b33-4a96-bf33-8e6bab14bf0c | 4 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | f330b7a0-bbe0-0f00-e053-2a95a90a37b8 | 4 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | 7769ad3d-6228-4b2d-8f44-4efe990d3fad | 4 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | f330b7a0-bbe0-0f00-e053-2a95a90a37b8 | 4 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | 3b1f5585-9b33-4a96-bf33-8e6bab14bf0c | 4 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | 7769ad3d-6228-4b2d-8f44-4efe990d3fad | 4 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | 8e830697-a6d3-13ed-e053-2995a90acb11 | 3 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | 8e830697-a6d3-13ed-e053-2995a90acb11 | 3 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | 726ff3a5-8559-4c2b-9be6-11ffa3c2cada | 2 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | 97f3f988-6bf1-453c-9be2-6671119a6f0b | 2 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | 726ff3a5-8559-4c2b-9be6-11ffa3c2cada | 2 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | 97f3f988-6bf1-453c-9be2-6671119a6f0b | 2 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | a966bf93-9053-13df-e053-2a95a90a075a | 1 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | afc6a3aa-e43d-4f10-bdbd-570a149bf9db | 1 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | 427b6ffb-3ff4-932f-e063-6394a90ae8b9 | 1 |
| 863664 | oxyBUTYnin chloride 5 MG Oral Tablet | PSN | 5e3b454b-6d3c-418b-8ac2-b0e17f018bbf | 1 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | 427b6ffb-3ff4-932f-e063-6394a90ae8b9 | 1 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | 5e3b454b-6d3c-418b-8ac2-b0e17f018bbf | 1 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | a966bf93-9053-13df-e053-2a95a90a075a | 1 |
| 863664 | oxybutynin chloride 5 MG Oral Tablet | SCD | afc6a3aa-e43d-4f10-bdbd-570a149bf9db | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70954-005-10 | 70954000510 | 100 TABLET in 1 BOTTLE (70954-005-10) | 100 tablet | 2017-11-15 | 0000-00-00 | No | No | Current |
| 70954-005-20 | 70954000520 | 500 TABLET in 1 BOTTLE (70954-005-20) | 500 tablet | 2017-11-15 | 0000-00-00 | No | No | Current |
| 70954-005-30 | 70954000530 | 1000 TABLET in 1 BOTTLE (70954-005-30) | 1000 tablet | 2017-11-15 | 0000-00-00 | No | No | Current |
| 70954-005-40 | 70954000540 | 1 in 1 BLISTER PACK | Historical | |||||
| 70954-005-50 | 70954000550 | 100 BLISTER PACK in 1 CARTON (70954-005-50) / 1 TABLET in 1 BLISTER PACK (70954-005-40) | 100 blister pack | 2021-08-20 | 0000-00-00 | No | No | Current |