Hyoscyamine Sulfate

Product NDC
43199-013
11-digit product format
431990013
Labeler code
43199
Product ID
43199-013_2fffb27c-9db5-4bc0-bbd6-ce8112c286ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
County Line Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-11-05
Marketing end
2023-08-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43199-013DDiscontinued by firm2026-08-11
excluded packagepackage43199-01343199-013-01DDiscontinued by firm2026-08-11

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 · 24 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 packagepackage43199-013-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43199-013-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43199-013-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43199-013-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43199-013-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43199-013-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43199-013-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43199-013-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43199-013-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43199-013-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43199-013-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43199-013-01557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43199-013-01EA - Each43199-0130e7f959b-d2d8-4dab-b2d1-386c3745838112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]2
HYOSCYAMINEACTIVE MOIETYPX44XO846XHYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]2
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84HYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]1
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84HYOSCYAMINE SULFATE TABLET [COUNTY LINE PHARMACEUTICALS, LLC]1
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84HYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYOSCYAMINEACTIVE MOIETYPX44XO846XHYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]1
HYOSCYAMINEACTIVE MOIETYPX44XO846XHYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYOSCYAMINEACTIVE MOIETYPX44XO846XHYOSCYAMINE SULFATE TABLET [COUNTY LINE PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYOSCYAMINE SULFATE TABLET [COUNTY LINE PHARMACEUTICALS, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYOSCYAMINE SULFATE TABLET [COUNTY LINE PHARMACEUTICALS, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYOSCYAMINE SULFATE TABLET [COUNTY LINE PHARMACEUTICALS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYOSCYAMINE SULFATE TABLET [COUNTY LINE PHARMACEUTICALS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYOSCYAMINE SULFATE TABLET [PROFICIENT RX LP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSN04895e7e-0faa-4c4a-a1c1-203743608a3f3
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCD04895e7e-0faa-4c4a-a1c1-203743608a3f3
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNe219b697-45d8-4388-8c79-4b98961fc5252
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDe219b697-45d8-4388-8c79-4b98961fc5252
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNbd6b5ea7-5823-4d13-bfda-4df96a73e1fb1
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDbd6b5ea7-5823-4d13-bfda-4df96a73e1fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43199-013-0143199001301100 TABLET in 1 BOTTLE (43199-013-01) 100 tablet2009-11-052023-08-01NoNoCurrent