FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
63187-058
11-digit product format
631870058
Labeler code
63187
Product ID
63187-058_dfeba17c-c430-4fdc-b18a-1f30c366e07e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL; SUBLINGUAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-09-21
Marketing end
0000-00-00
Substance
HYOSCYAMINE SULFATE
Active strength
0 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-058DDiscontinued by firm2026-10-05
excluded packagepackage63187-05863187-058-10DDiscontinued by firm2026-10-05
excluded packagepackage63187-05863187-058-15DDiscontinued by firm2026-10-05

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-058-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-058-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-058-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-058-15f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84HYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]2
HYOSCYAMINEACTIVE MOIETYPX44XO846XHYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AHYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]2
SORBITOLINACTIVE INGREDIENT506T60A25RHYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-058HYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]6Legacy NDC20200403_dba6c34f-82e4-49fc-bbe3-97eaabaac1d3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-058-106318700581010 TABLET in 1 BOTTLE (63187-058-10) 10 tablet2015-02-020000-00-00NoNoCurrent
63187-058-156318700581515 TABLET in 1 BOTTLE (63187-058-15) 15 tablet2015-02-020000-00-00NoNoCurrent