Oxybutynin Chloride
- Product NDC
- 50090-4192
- Requested package NDC
- 50090-4192-0
- 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
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 package | package | 50090-4192 | 50090-4192-0 | I | Inactivated by FDA | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
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… |
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 |
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 |
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 |