Oxybutynin Chloride
- Product NDC
- 70518-1030
- 11-digit product format
- 705181030
- Labeler code
- 70518
- Product ID
- 70518-1030_8ff9bedd-a8fc-7969-e053-2a95a90aae62
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxybutynin chloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075079
- Marketing category
- ANDA
- Marketing start
- 2018-02-21
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-1030 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 70518-1030 | 70518-1030-0 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075079-001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET / ORAL | AB | 1997-10-31 | |
| A075079-002 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 2.5MG | TABLET / ORAL | AB | 2026-03-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075079-001 | AB |
| A075079-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075079-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET / ORAL | AB | 1997-10-31 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075079-002 | OXYBUTYNIN CHLORIDE | 2.5MG | TABLET / ORAL | AB | 2026-03-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075079-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075079-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Strides Pharma Science Limited | 9ede5def-d185-4e40-9c10-8663ac654caf | 2026-07-01 | Warnings, Adverse reactions | 075079 ANDA075079 |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 2425f49f-ade3-5178-e063-6294a90adfac | 2024-10-10 | Warnings, Adverse reactions | 075079 ANDA075079 |