Home NDC 14539-653-05 Oxybutynin Chloride
Product NDC 14539-653
Requested package NDC 14539-653-05
11-digit product format 145390653
Labeler code 14539
Product ID 14539-653_5702ab99-0517-411e-9fb1-d6b1f415a790
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxybutynin Chloride
Dosage form TABLET
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA211682
Marketing category ANDA
Marketing start 2019-06-01
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 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.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211682-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211682-001 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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table 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 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2019-05-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2019-05-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211682-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL BX 2019-05-10 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxybutynin Chloride OXYBUTYNIN CHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 73d715dc-868d-4194-b668-4c39ababa698 2026-05-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211682 application number: ANDA211682
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 14539-653-05 14539065305 500 TABLET in 1 BOTTLE, PLASTIC (14539-653-05) 500 tablet 2019-06-01 0000-00-00 No No Current