Hyosyne

Product NDC
17856-0511
Requested package NDC
17856-0511-2
11-digit product format
178560511
Labeler code
17856
Product ID
17856-0511_34f49010-b93e-d787-e063-6294a90abcf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
ELIXIR
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1997-11-01
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-051117856-0511-2IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Hyosyne
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/5mL

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
1047881Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d022cde6-90c7-48b5-8022-cf7b76f4da19Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0511-1Hyosyne5 mL in 1 CUPELIXIR512
17856-0511-2Hyosyne10 mL in 1 CUPELIXIR1012
17856-0511-2Hyosyne72 in 1 BOXELIXIR7212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0511HYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [ATLANTIC BIOLOGICALS CORP.]12Current NDC, Legacy NDC, 3 package rows20250514_d022cde6-90c7-48b5-8022-cf7b76f4da19.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
HyosyneHYOSCYAMINE SULFATEATLANTIC BIOLOGICALS CORP.d022cde6-90c7-48b5-8022-cf7b76f4da192025-05-12Warnings, Adverse reactionsExact identifier
ndc (package): 17856-0511-2
ndc (product): 17856-0511
ndc11 (package): 17856051102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047881hyoscyamine sulfate 0.125 MG in 5 mL Oral SolutionPSNd022cde6-90c7-48b5-8022-cf7b76f4da1912
1047881hyoscyamine sulfate 0.025 MG/ML Oral SolutionSCDd022cde6-90c7-48b5-8022-cf7b76f4da1912
1047881hyoscyamine sulfate 0.125 MG per 5 ML Oral SolutionSYd022cde6-90c7-48b5-8022-cf7b76f4da1912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0511-21785605110272 CUP in 1 BOX (17856-0511-2) / 10 mL in 1 CUP72 cup2024-04-100000-00-00NoNoCurrent