FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
51655-764
11-digit product format
516550764
Labeler code
51655
Product ID
51655-764_4951b9e0-bb6b-e2d6-e063-6394a90a8160
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-07-19
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine Sulfate
Listing expiration
2027-12-31

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
1047905Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da704abd-4e60-f32e-e053-2a95a90a2830Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-764-52Hyoscyamine Sulfate30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-764HYOSCYAMINE SULFATE TABLET [NORTHWIND PHARMACEUTICALS]1Current NDC, 1 package rows20230419_da704abd-4e60-f32e-e053-2a95a90a2830.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 SULFATENorthwind Health Company, LLCda704abd-4e60-f32e-e053-2a95a90a28302026-01-01Warnings, Adverse reactionsExact identifier
ndc (product): 51655-764

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNda704abd-4e60-f32e-e053-2a95a90a28302
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDda704abd-4e60-f32e-e053-2a95a90a28302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-764-525165507645230 TABLET in 1 BOTTLE, PLASTIC (51655-764-52) 30 tablet2021-07-19NoNoCurrent