Oxybutynin Chloride
- Product NDC
- 63739-548
- 11-digit product format
- 637390548
- Labeler code
- 63739
- Product ID
- 63739-548_b8f7d560-0e44-d1a0-e053-2a95a90a13b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- McKesson Corporation dba SKY Packaging
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63739-548 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 63739-548 | 63739-548-33 | D | Discontinued by firm | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 63739-548 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63739-548 | 63739-548-33 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078503-001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | |
| A078503-002 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | |
| A078503-003 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078503-001 | AB |
| A078503-002 | AB |
| A078503-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078503-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078503-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63739-548-33 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3394-f274-e053-dbdaa90a6471 | 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 for oral use Initial U.S. Approval: 1975 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-548-33 | EA - Each | 63739-548 | eec64698-2909-4c28-a587-9538fd3452a7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | American Health Packaging | 0c71bdfb-01db-49ac-a8e9-0037df0d24af | 2026-06-24 | Warnings, Adverse reactions | 078503 ANDA078503 |
| oxybutynin chloride | OXYBUTYNIN CHLORIDE | Chartwell RX, LLC | e464c8dd-5222-4a6b-b7e9-ca608a403c6e | 2025-12-22 | Warnings, Adverse reactions | 078503 ANDA078503 |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | AvKARE | 94471401-a516-0fe7-ec9c-447dd2bee972 | 2025-12-16 | Warnings, Adverse reactions | 078503 ANDA078503 |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | PD-Rx Pharmaceuticals, Inc. | b5653b7e-1e3b-4da3-b3a2-33318f448c67 | 2025-10-20 | Warnings, Adverse reactions | 078503 ANDA078503 |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | AvPAK | 242b4766-bc2b-0073-d72d-1bf879bbee24 | 2025-04-17 | Warnings, Adverse reactions | 078503 ANDA078503 |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2023-05-31 | Warnings, Adverse reactions | 078503 ANDA078503 |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Lannett Company, Inc. | c5950dba-d92b-46a0-993f-af9f9ddb52bf | 2023-05-30 | Warnings, Adverse reactions | 078503 ANDA078503 |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | e985e201-2fb3-4781-9790-a1a3db1ae2a1 | 2017-10-20 | Warnings, Adverse reactions | 078503 ANDA078503 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63739-548-33 | 63739054833 | 3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-548-33) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2009-03-01 | 0000-00-00 | No | No | Current |