Symax Duotab

Product NDC: 64543-118
11-digit product format: 645430118
Labeler code: 64543
Product ID: 64543-118_edfed750-effe-3cfa-e053-2995a90a56c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hyoscyamine Sulfate
Dosage form: TABLET, MULTILAYER, EXTENDED RELEASE
Route: ORAL
Labeler: Capellon Pharmaceuticals, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2009-11-07
Marketing end: 0000-00-00
Substance: HYOSCYAMINE SULFATE
Active strength: 0 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64543-118		D	Discontinued by firm	2026-10-12
excluded package	package	64543-118	64543-118-02	D	Discontinued by firm	2026-10-12
excluded package	package	64543-118	64543-118-90	D	Discontinued by firm	2026-10-12

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 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64543-118-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64543-118-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64543-118-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64543-118-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64543-118-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64543-118-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64543-118-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64543-118-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64543-118-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64543-118-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64543-118-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64543-118-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64543-118-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64543-118-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64543-118-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64543-118-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64543-118-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64543-118-02	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64543-118-90	EA - Each	64543-118	6e69aa1e-468b-445e-96e9-7334de7ae29a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYOSCYAMINE SULFATE	ACTIVE INGREDIENT	F2R8V82B84	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
HYOSCYAMINE	ACTIVE MOIETY	PX44XO846X	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
CALCIUM PHOSPHATE	INACTIVE INGREDIENT	97Z1WI3NDX	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F2R8V82B84	HYOSCYAMINE SULFATE	6835-16-1	HYOSCYAMINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64543-118-02	64543011802	12 POUCH in 1 CARTON (64543-118-02) > 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 POUCH	12 pouch	2009-11-07	0000-00-00	Yes	No	Current
64543-118-90	64543011890	90 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64543-118-90)		2009-11-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Symax ® Duotab Hyoscyamine Sulfate BIPHASIC TABLETS* Rx Only *U.S. Patent No. 9,308,164	Capellon Pharmaceuticals, LLC	2023-08-21	HUMAN PRESCRIPTION DRUG LABEL	9