Flavoxate Hydrochloride

Product NDC: 50268-324
Requested package NDC: 50268-324-15
11-digit product format: 502680324
Labeler code: 50268
Product ID: 50268-324_6891f74f-8163-dc20-e053-2a91aa0af588
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flavoxate Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA076835
Marketing category: ANDA
Marketing start: 2012-11-30
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50268-324	50268-324-15	D	Discontinued by firm		2026-08-17

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 · 12 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…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076835-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076835-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076835-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076835-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076835-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076835-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076835-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076835-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076835-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076835-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076835-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076835-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076835-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076835-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076835-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076835-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076835-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076835-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076835-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076835-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076835-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076835-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076835-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076835-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076835-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076835-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076835-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076835-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076835-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076835-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076835-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076835-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076835-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076835-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076835-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076835-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076835-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076835-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076835-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076835-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-324-11	EA - Each	50268-324	236d4bea-735e-458c-8d40-b6ade91f20f7	1	2015-04-03
50268-324-15	EA - Each	50268-324	f51880e1-a394-442b-a3c0-8241225e4eae	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flavoxate Hydrochloride	FLAVOXATE HYDROCHLORIDE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076835 application number: ANDA076835
Flavoxate Hydrochloride	FLAVOXATE HYDROCHLORIDE	Epic Pharma, LLC	b4260d7e-2ab3-49f6-aa57-bae19a23d82a	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076835 application number: ANDA076835

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9C05J6089W	FLAVOXATE HYDROCHLORIDE	3717-88-2	FLAVOXATE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-324-15	50268032415	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-324-15) > 1 TABLET in 1 BLISTER PACK (50268-324-11)	50 blister pack	2012-11-30	0000-00-00	No	No	Current