Home NDC 43353-367-30 Oxybutynin Chloride
Product NDC 43353-367
Requested package NDC 43353-367-30
11-digit product format 433530367
Labeler code 43353
Product ID 43353-367_f1a9c987-5f09-45f3-8c21-8a8cbc34cf88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxybutynin chloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075079
Marketing category ANDA
Marketing start 1997-10-31
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 2020-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075079-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1997-10-31 A075079-002 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 2.5MG TABLET / ORAL AB 2026-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 44 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 2026-08-18 06:07:40 2026-07 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1997-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075079-002 OXYBUTYNIN CHLORIDE 2.5MG TABLET / ORAL AB 2026-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1997-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB RS 1997-10-31 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-367-30 Oxybutynin Chloride 30 in 1 BOTTLE, PLASTIC TABLET 30 2 43353-367-60 Oxybutynin Chloride 90 in 1 BOTTLE, PLASTIC TABLET 90 2 43353-367-80 Oxybutynin Chloride 180 in 1 BOTTLE, PLASTIC TABLET 180 2 43353-367-92 Oxybutynin Chloride 270 in 1 BOTTLE, PLASTIC TABLET 270 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXYBUTYNIN CHLORIDE ACTIVE INGREDIENT L9F3D9RENQ OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 OXYBUTYNIN ACTIVE MOIETY K9P6MC7092 OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-367 OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 4 package rows 20191221_fad7574c-07fc-4311-90ea-5ccc7244e782.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 43353-367-30 43353036730 30 TABLET in 1 BOTTLE, PLASTIC (43353-367-30) 30 tablet 2008-10-10 0000-00-00 No No Current