Hyoscyamine Sulfate

Product NDC
39328-049
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 Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046985

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

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) 2024-08-15NoNoHistorical