FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
39328-049
Requested package NDC
39328-049-10
11-digit product format
393280049
Labeler code
39328
Product ID
39328-049_4b78f940-803f-4a1d-a231-cfedffa53c96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Patrin Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-08-15
Substance
HYOSCYAMINE SULFATE
Active strength
.125 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.125 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
1046985Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56910c34-cf78-4dcd-a594-6efec255e695Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-049-10Hyoscyamine Sulfate100 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-049-10EA - Each39328-049f33492c2-f0ff-4b73-b15c-4bf0b55e427112024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-049HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING [PATRIN PHARMA, INC.]1Current NDC, 1 package rows20240905_56910c34-cf78-4dcd-a594-6efec255e695.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.56910c34-cf78-4dcd-a594-6efec255e6952024-09-03Warnings, Adverse reactionsExact identifier
ndc (package): 39328-049-10
ndc (product): 39328-049
ndc11 (package): 39328004910

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN56910c34-cf78-4dcd-a594-6efec255e6951
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD56910c34-cf78-4dcd-a594-6efec255e6951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
39328-049-1039328004910100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (39328-049-10) 2024-08-15NoNoCurrent