Home NDC 24658-720 Flavoxate Hydrochloride
Product NDC 24658-720
11-digit product format 246580720
Labeler code 24658
Product ID 24658-720_cdb3dd6e-969c-4f0c-888b-a3e1b7062fda
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flavoxate Hydrochloride
Dosage form TABLET
Route ORAL
Labeler PuraCap Laboratories LLC dba Blu Pharmaceuticals
Application ANDA076835
Marketing category ANDA
Marketing start 2016-12-15
Substance FLAVOXATE HYDROCHLORIDE
Active strength 100 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 42 .
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 A076835-001 FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076835-001 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 · 42 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 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076835-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB 2005-11-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Flavoxate Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLAVOXATE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9C05J6089W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1095229 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24658-720-01 Flavoxate Hydrochloride 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24658-720 FLAVOXATE HYDROCHLORIDE TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 1 package rows 20211110_f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88.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 24658-720-01 24658072001 100 TABLET in 1 BOTTLE (24658-720-01) 100 tablet 2016-12-15 0000-00-00 No No Current