Hyoscyamine Sulfate

Product NDC
39328-051
11-digit product format
393280051
Labeler code
39328
Product ID
39328-051_71075d9f-2f06-4893-b954-5619f41c3f0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
SUBLINGUAL
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
Rxcui1046982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-051-10Hyoscyamine Sulfate100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-051-10EA - Each39328-051f8dd55f4-82e3-4424-b324-df19894df2bf12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-051HYOSCYAMINE SULFATE TABLET [PATRIN PHARMA, INC.]1Current NDC, 1 package rows20240906_cd79f902-2a7b-4f3f-ac17-beaa254adfbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSNcd79f902-2a7b-4f3f-ac17-beaa254adfbc1
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCDcd79f902-2a7b-4f3f-ac17-beaa254adfbc1
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSYcd79f902-2a7b-4f3f-ac17-beaa254adfbc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39328-051-1039328005110100 TABLET in 1 BOTTLE, PLASTIC (39328-051-10) 100 tablet2024-08-15NoNoHistorical