FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2R8V82B84Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046770Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5bbce8c0-a9c9-45b9-8457-1542bd3d9449Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine ERHYOSCYAMINE SULFATEMylan Pharmaceuticals Inc.5bbce8c0-a9c9-45b9-8457-1542bd3d94492023-07-15Warnings, Adverse reactionsExact identifier
ndc (product): 51525-0115

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