FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
72162-1940
Requested package NDC
72162-1940-1
11-digit product format
721621940
Labeler code
72162
Product ID
72162-1940_5262f3f6-d5a6-4350-83d8-2ee415f0169a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-10-01
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
1046982Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db2dc70e-b2ae-4d65-9c2d-ed4bdfb3c0e7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1940-1Hyoscyamine Sulfate100 in 1 BOTTLETABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1940-1EA - Each72162-19400a66c84f-3dab-4cd5-bd69-e9288d18cc5a12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1940HYOSCYAMINE SULFATE TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20230901_db2dc70e-b2ae-4d65-9c2d-ed4bdfb3c0e7.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 SULFATEBryant Ranch Prepackdb2dc70e-b2ae-4d65-9c2d-ed4bdfb3c0e72023-08-28Warnings, Adverse reactionsExact identifier
ndc (package): 72162-1940-1
ndc (product): 72162-1940
ndc11 (package): 72162194001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSNdb2dc70e-b2ae-4d65-9c2d-ed4bdfb3c0e7100
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCDdb2dc70e-b2ae-4d65-9c2d-ed4bdfb3c0e7100
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSYdb2dc70e-b2ae-4d65-9c2d-ed4bdfb3c0e7100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1940-172162194001100 TABLET in 1 BOTTLE (72162-1940-1) 100 tablet2023-08-28NoNoCurrent