Home NDC 71335-0519 Oxybutynin Chloride
Product NDC 71335-0519
11-digit product format 713350519
Labeler code 71335
Product ID 71335-0519_46064d9f-6de0-4f4c-8b9a-70fdd5e4af72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxybutynin Chloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA071655
Marketing category ANDA
Marketing start 1990-09-30
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 A071655-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071655-001 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 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071655-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1988-11-14 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 71335-0519-1 Oxybutynin Chloride 30 in 1 BOTTLE TABLET 30 5 71335-0519-2 Oxybutynin Chloride 100 in 1 BOTTLE TABLET 100 5 71335-0519-3 Oxybutynin Chloride 20 in 1 BOTTLE TABLET 20 5 71335-0519-4 Oxybutynin Chloride 60 in 1 BOTTLE TABLET 60 5 71335-0519-5 Oxybutynin Chloride 90 in 1 BOTTLE TABLET 90 5 71335-0519-6 Oxybutynin Chloride 42 in 1 BOTTLE TABLET 42 5 71335-0519-7 Oxybutynin Chloride 15 in 1 BOTTLE TABLET 15 5 71335-0519-8 Oxybutynin Chloride 180 in 1 BOTTLE TABLET 180 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0519 OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK] 5 Current NDC, Legacy NDC, 8 package rows 20241004_246d2f79-8ab5-4023-9068-1451b695ac16.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 · 4 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 71335-0519-1 71335051901 30 TABLET in 1 BOTTLE (71335-0519-1) 30 tablet 2008-07-22 0000-00-00 No No Current 71335-0519-2 71335051902 100 TABLET in 1 BOTTLE (71335-0519-2) 100 tablet 2008-07-22 0000-00-00 No No Current 71335-0519-3 71335051903 20 TABLET in 1 BOTTLE (71335-0519-3) 20 tablet 2008-07-22 0000-00-00 No No Current 71335-0519-4 71335051904 60 TABLET in 1 BOTTLE (71335-0519-4) 60 tablet 2008-07-22 0000-00-00 No No Current 71335-0519-5 71335051905 90 TABLET in 1 BOTTLE (71335-0519-5) 90 tablet 2008-07-22 0000-00-00 No No Current 71335-0519-6 71335051906 42 TABLET in 1 BOTTLE (71335-0519-6) 42 tablet 2008-07-22 0000-00-00 No No Current 71335-0519-7 71335051907 15 TABLET in 1 BOTTLE (71335-0519-7) 15 tablet 2008-07-22 0000-00-00 No No Current 71335-0519-8 71335051908 180 TABLET in 1 BOTTLE (71335-0519-8) 180 tablet 2008-07-22 0000-00-00 No No Current