Home NDC 43353-978 Oxybutynin Chloride
Product NDC 43353-978
11-digit product format 433530978
Labeler code 43353
Product ID 43353-978_c8f0373d-45aa-49dc-8436-4fc1a9304a57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxybutynin Chloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA074625
Marketing category ANDA
Marketing start 2011-11-07
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 2026-12-31
Current FDA listing Yes 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 A074625-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074625-001 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 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074625-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1996-07-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxybutynin Chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYBUTYNIN CHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L9F3D9RENQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 863664 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-978-92 Oxybutynin Chloride 270 in 1 BOTTLE TABLET 270 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-978 OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20160708_58136f28-70c1-4cf2-bcd7-858c5609431a.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.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43353-978-92 43353097892 270 TABLET in 1 BOTTLE (43353-978-92) 270 tablet 2014-11-01 0000-00-00 No No Current