Hyoscyamine

Product NDC
51525-0115
11-digit product format
515250115
Labeler code
51525
Product ID
51525-0115_0522d7a7-0349-48e2-85d9-827963cc4986
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-05-01
Substance
HYOSCYAMINE SULFATE
Active strength
.375 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
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046770

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51525-0115-1HyoscyamineER100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51525-0115-1EA - Each51525-011585cd83a7-0a00-424b-8c00-f285e52ec8aa12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51525-0115HYOSCYAMINE ER (HYOSCYAMINE SULFATE) TABLET, EXTENDED RELEASE [WALLACE PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20181219_5bbce8c0-a9c9-45b9-8457-1542bd3d9449.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046770hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral TabletPSN5bbce8c0-a9c9-45b9-8457-1542bd3d94494
104677012 HR hyoscyamine sulfate 0.375 MG Extended Release Oral TabletSCD5bbce8c0-a9c9-45b9-8457-1542bd3d94494
1046770hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral TabletSY5bbce8c0-a9c9-45b9-8457-1542bd3d94494
1046770hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral TabletSY5bbce8c0-a9c9-45b9-8457-1542bd3d94494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51525-0115-151525011501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51525-0115-1) 2016-05-010000-00-00NoNoCurrent