Home NDC 60687-670 Oxybutynin Chloride
Product NDC 60687-670
11-digit product format 606870670
Labeler code 60687
Product ID 60687-670_e5d1e71e-2817-b092-e053-2a95a90ab1e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxybutynin chloride
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA075079
Marketing category ANDA
Marketing start 2022-07-20
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 2023-12-31
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 · 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 60687-670 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60687-670 60687-670-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-670 OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 3 Legacy NDC 20250328_a70df67f-b02b-42a5-b4b1-34b93398f1bf.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-670-01 60687067001 100 BLISTER PACK in 1 CARTON (60687-670-01) > 1 TABLET in 1 BLISTER PACK (60687-670-11) 100 blister pack 2022-07-20 0000-00-00 No No Current