Hyoscyamine Sulfate

Product NDC: 76439-308
Requested package NDC: 76439-308-10
11-digit product format: 764390308
Labeler code: 76439
Product ID: 76439-308_8a0e1dae-56af-4138-abcc-da3e69438246
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hyoscyamine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Virtus Pharmaceuticals
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-09-04
Marketing end: 2021-05-31
Substance: HYOSCYAMINE SULFATE
Active strength: 0 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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	76439-308	76439-308-10	D	Discontinued by firm		2026-10-05

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…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76439-308-10	EA - Each	76439-308	69837ea4-9370-4b77-8cd5-71a06f185e6d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hyoscyamine Sulfate	ACTIVE INGREDIENT	F2R8V82B84	HYOSCYAMINE SULFATE TABLET [VIRTUS PHARMACEUTICALS]	2
Hyoscyamine	ACTIVE MOIETY	PX44XO846X	HYOSCYAMINE SULFATE TABLET [VIRTUS PHARMACEUTICALS]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	HYOSCYAMINE SULFATE TABLET [VIRTUS PHARMACEUTICALS]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	HYOSCYAMINE SULFATE TABLET [VIRTUS PHARMACEUTICALS]	2
mannitol	INACTIVE INGREDIENT	3OWL53L36A	HYOSCYAMINE SULFATE TABLET [VIRTUS PHARMACEUTICALS]	2
Hyoscyamine Sulfate	ACTIVE INGREDIENT	F2R8V82B84	DIRECT RX (HYOSCYAMINE SULFATE) TABLET [DIRECT RX]	1
HYOSCYAMINE	ACTIVE MOIETY	PX44XO846X	DIRECT RX (HYOSCYAMINE SULFATE) TABLET [DIRECT RX]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	DIRECT RX (HYOSCYAMINE SULFATE) TABLET [DIRECT RX]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DIRECT RX (HYOSCYAMINE SULFATE) TABLET [DIRECT RX]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	DIRECT RX (HYOSCYAMINE SULFATE) TABLET [DIRECT RX]	1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1047905	hyoscyamine sulfate 0.125 MG Oral Tablet	PSN	03093c69-2638-408f-8a9c-6c43d279e4cb	4
1047905	hyoscyamine sulfate 0.125 MG Oral Tablet	SCD	03093c69-2638-408f-8a9c-6c43d279e4cb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76439-308-10	76439030810	100 TABLET in 1 BOTTLE (76439-308-10)	100 tablet	2011-09-04	2021-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYOSCYAMINE SULFATE TABLETS, USP 0.125 mg	Virtus Pharmaceuticals	2021-04-02	HUMAN PRESCRIPTION DRUG LABEL	5
Hyoscyamine Sulfate	Direct_Rx	2019-09-18	HUMAN PRESCRIPTION DRUG LABEL	4