Hyoscyamine Sulfate

Product NDC
53217-063
11-digit product format
532170063
Labeler code
53217
Product ID
53217-063_b50ba291-8672-4722-99a8-73aa624ad39b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-11-05
Marketing end
0000-00-00
Substance
HYOSCYAMINE SULFATE
Active strength
0 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-063-212020-01-31C16284748780-19d75b9d0-1e3d-f424-e053-dadaa90a57ceHyoscyamine Sulfate Tablets, USP, 0.125 mg PI-9326 Rev 02/09 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-063-21Hyoscyamine Sulfate21 in 1 BOTTLE, PLASTICTABLET211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84HYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYOSCYAMINEACTIVE MOIETYPX44XO846XHYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-063HYOSCYAMINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140214_bd6b5ea7-5823-4d13-bfda-4df96a73e1fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
53217-063-215321700632121 in 1 BOTTLE, PLASTICHistorical