FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
39328-052
11-digit product format
393280052
Labeler code
39328
Product ID
39328-052_960e2d7a-ba1c-42eb-9749-80a7395911a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Patrin Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-08-16
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 Sulfate
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
d7189f97-d570-4662-8f1d-cf1da02f01ecAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-052-10Hyoscyamine Sulfate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-052-10EA - Each39328-0524feabc67-d43b-4c5e-8375-9ec93f0d6f7f12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-052HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE [PATRIN PHARMA, INC.]1Current NDC, 1 package rows20240906_d7189f97-d570-4662-8f1d-cf1da02f01ec.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 SulfateHYOSCYAMINE SULFATEPatrin Pharma, Inc.d7189f97-d570-4662-8f1d-cf1da02f01ec2024-09-03Warnings, Adverse reactionsExact identifier
ndc (product): 39328-052

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046770hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral TabletPSNd7189f97-d570-4662-8f1d-cf1da02f01ec1
104677012 HR hyoscyamine sulfate 0.375 MG Extended Release Oral TabletSCDd7189f97-d570-4662-8f1d-cf1da02f01ec1
1046770hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral TabletSYd7189f97-d570-4662-8f1d-cf1da02f01ec1
1046770hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral TabletSYd7189f97-d570-4662-8f1d-cf1da02f01ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
39328-052-1039328005210100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (39328-052-10) 2024-08-16NoNoCurrent