Hyoscyamine Sulfate

Product NDC
63561-0197
11-digit product format
635610197
Labeler code
63561
Product ID
63561-0197_4f86347a-9346-8ff6-e063-6294a90a59c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Granulation Technology, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-04-16
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046985

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0197-1Hyoscyamine Sulfate100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN51a07955-485f-1357-e063-6394a90ad3f82
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD51a07955-485f-1357-e063-6394a90ad3f82
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN4f863ae9-d010-b2f5-e063-6394a90a1a951
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD4f863ae9-d010-b2f5-e063-6394a90a1a951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63561-0197-163561019701100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63561-0197-1) 2026-04-16NoNoCurrent