Home NDC 42806-058 Flavoxate Hydrochloride
Product NDC 42806-058
11-digit product format 428060058
Labeler code 42806
Product ID 42806-058_6aeb8856-3df7-40a7-b03e-d855a58c8fa4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flavoxate Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA076835
Marketing category ANDA
Marketing start 2011-02-21
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 42806-058-01 Flavoxate Hydrochloride 100 in 1 BOTTLE TABLET 100 11 42806-058-10 Flavoxate Hydrochloride 1000 in 1 BOTTLE TABLET 1000 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLAVOXATE HYDROCHLORIDE ACTIVE INGREDIENT 9C05J6089W FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 FLAVOXATE ACTIVE MOIETY 3E74Y80MEY FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 HYPROMELLOSE 2910 (50 MPA.S) INACTIVE INGREDIENT 1IVH67816N FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 4 FLAVOXATE HYDROCHLORIDE ACTIVE INGREDIENT 9C05J6089W FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 FLAVOXATE ACTIVE MOIETY 3E74Y80MEY FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) INACTIVE INGREDIENT 87Y6436BKR FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FLAVOXATE HYDROCHLORIDE (FLAVOXATE HYDROCHLORIDE) TABLET [AVPAK] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-058 FLAVOXATE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20231228_b4260d7e-2ab3-49f6-aa57-bae19a23d82a.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 42806-058-01 42806005801 100 TABLET in 1 BOTTLE (42806-058-01) 100 tablet 2011-02-21 0000-00-00 No No Current 42806-058-10 42806005810 1000 TABLET in 1 BOTTLE (42806-058-10) 1000 tablet 2011-02-21 0000-00-00 No No Current