Hyoscyamine Sulfate

Product NDC
62559-422
11-digit product format
625590422
Labeler code
62559
Product ID
62559-422_e60b7fbe-fdd5-4932-9f26-cecdeb5c60d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-02-15
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-422-01Hyoscyamine Sulfate100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-422-01EA - Each62559-4223a17e9f9-c1fd-417d-bbcc-6f8232ab626612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-422HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240215_66fdfc33-a7b9-465b-84f1-012cdf5517fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN66fdfc33-a7b9-465b-84f1-012cdf5517fd2
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD66fdfc33-a7b9-465b-84f1-012cdf5517fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62559-422-0162559042201100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62559-422-01) 2024-02-15NoNoCurrent