Home NDC 23155-810 Oxybutynin Chloride
Product NDC 23155-810
11-digit product format 231550810
Labeler code 23155
Product ID 23155-810_e12456ec-640f-45a5-b78a-66e22c36d24a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxybutynin Chloride
Dosage form TABLET
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA208165
Marketing category ANDA
Marketing start 2022-01-31
Marketing end 2027-08-31
Substance OXYBUTYNIN CHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
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 A208165-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208165-001 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.
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 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2020-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2020-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2020-12-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2020-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2020-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL 2020-12-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208165-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-12-17 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Oxybutynin Chloride 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 23155-810-01 Oxybutynin Chloride 100 in 1 BOTTLE TABLET 100 3 23155-810-05 Oxybutynin Chloride 500 in 1 BOTTLE TABLET 500 3 23155-810-10 Oxybutynin Chloride 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-810 OXYBUTYNIN CHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 1 Current NDC, Legacy NDC, 3 package rows 20220131_9a551ec5-7e80-47c9-a7b9-f458c1478174.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 · 5 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 23155-810-01 23155081001 100 TABLET in 1 BOTTLE (23155-810-01) 100 tablet 2022-01-31 2027-07-31 No No Current 23155-810-05 23155081005 500 TABLET in 1 BOTTLE (23155-810-05) 500 tablet 2022-01-31 2027-08-31 No No Current 23155-810-10 23155081010 1000 TABLET in 1 BOTTLE (23155-810-10) 1000 tablet 2022-01-31 2027-07-31 No No Current