OXYBUTYNIN CHLORIDE
- Product NDC
- 0121-0671
- 11-digit product format
- 001210671
- Labeler code
- 0121
- Product ID
- 0121-0671_2000b665-7d6f-415b-b9d5-d4eca54a241b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYBUTYNIN CHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA075137
- Marketing category
- ANDA
- Marketing start
- 1998-12-18
- Marketing end
- 0000-00-00
- Substance
- OXYBUTYNIN CHLORIDE
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0121-0671-05 | 2022-12-14 | C162847 | 48780-1 | 9d75b9cf-f83f-f424-e053-dadaa90a57ce | 1c6dfc08-b177-41eb-9865-368252a1b8bb |
| 0121-0671-16 | 2022-12-14 | C162847 | 48780-1 | 9d75b9cf-f83f-f424-e053-dadaa90a57ce | 1c6dfc08-b177-41eb-9865-368252a1b8bb |
| 0121-0671-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f83f-f424-e053-dadaa90a57ce | 1c6dfc08-b177-41eb-9865-368252a1b8bb |
| 0121-0671-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f83f-f424-e053-dadaa90a57ce | 1c6dfc08-b177-41eb-9865-368252a1b8bb |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0671-05 | ML - Milliliter | 0121-0671 | c8badb82-4b8c-4172-9196-61ca8804472e | 1 | 2013-02-13 |
| 0121-0671-16 | ML - Milliliter | 0121-0671 | 8ec85f95-5e3d-4ace-9f7b-398d22f7afe3 | 1 | 2013-02-13 |