Hyoscyamine Sulfate

Product NDC
63561-0202
11-digit product format
635610202
Labeler code
63561
Product ID
63561-0202_4f230d21-e836-36a0-e063-6294a90ae156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Granulation Technology, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-04-13
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
Rxcui1046982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0202-1Hyoscyamine Sulfate100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSNd81bf93e-e73f-4b12-980b-33a5bf4531421
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCDd81bf93e-e73f-4b12-980b-33a5bf4531421
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSYd81bf93e-e73f-4b12-980b-33a5bf4531421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63561-0202-163561020201100 TABLET in 1 BOTTLE (63561-0202-1) 100 tablet2026-04-13NoNoCurrent