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 Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046770

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

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) 2024-08-16NoNoHistorical