Home NDC 0574-0115 FLAVOXATE HYDROCHLORIDE
Product NDC 0574-0115
11-digit product format 005740115
Labeler code 0574
Product ID 0574-0115_ff1c0ee9-75d2-478a-9152-0753be81ff11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLAVOXATE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Padagis US LLC
Application ANDA076831
Marketing category ANDA
Marketing start 2004-12-22
Marketing end 2026-12-31
Substance FLAVOXATE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
Current FDA listing Yes 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 A076831-001 FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076831-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076831-001 FLAVOXATE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2004-12-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base FLAVOXATE HYDROCHLORIDE 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 0574-0115-01 FLAVOXATE HYDROCHLORIDE 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLAVOXATE HYDROCHLORIDE ACTIVE INGREDIENT 9C05J6089W FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 FLAVOXATE ACTIVE MOIETY 3E74Y80MEY FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 ETHYL ACRYLATE INACTIVE INGREDIENT 71E6178C9T FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 METHYL METHACRYLATE INACTIVE INGREDIENT 196OC77688 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 NONOXYNOL-100 INACTIVE INGREDIENT A906T4D368 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC] 7 FLAVOXATE HYDROCHLORIDE ACTIVE INGREDIENT 9C05J6089W FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 FLAVOXATE ACTIVE MOIETY 3E74Y80MEY FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 ETHYL ACRYLATE INACTIVE INGREDIENT 71E6178C9T FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 METHYL METHACRYLATE INACTIVE INGREDIENT 196OC77688 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 NONOXYNOL-100 INACTIVE INGREDIENT A906T4D368 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0115 FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADAGIS US LLC] 11 Current NDC, Legacy NDC, 1 package rows 20240202_a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0574-0115-01 00574011501 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01) 2004-12-22 2026-12-31 No No Current