Home NDC 67296-2045-3 OXYBUTYNIN CHLORIDE
Product NDC 67296-2045
Requested package NDC 67296-2045-3
11-digit product format 672962045
Labeler code 67296
Product ID 67296-2045_2c6318c6-0896-4b52-e063-6394a90a4e53
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXYBUTYNIN CHLORIDE
Dosage form TABLET
Route ORAL
Labeler Redpharm Drug
Application ANDA212798
Marketing category ANDA
Marketing start 2019-11-01
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67296-2045 67296-2045-3 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67296-2045 67296-2045-3 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A212798-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212798-001 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 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212798-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 2020-04-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 67296-2045-3 OXYBUTYNIN CHLORIDE 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-2045 OXYBUTYNIN CHLORIDE TABLET [REDPHARM DRUG] 2 Current NDC, 1 package rows 20250124_fc4cfbe6-a940-41c0-e053-6294a90adb14.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 Sample Exclude flag Status 67296-2045-3 67296204503 30 TABLET in 1 BOTTLE (67296-2045-3) 30 tablet 2019-11-01 No No Current