Hyosyne

Product NDC
17856-0511
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-051117856-0511-1DDiscontinued by firm2026-08-11

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0511-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0511-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0511-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0511-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0511-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0511-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0511-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0511-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0511-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0511-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0511-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0511-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0511-2IInactivated by FDA1332a3947898…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 (product): 17856-0511

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
17856-0511-1178560511015 mL in 1 CUP5 mlHistorical
17856-0511-21785605110272 CUP in 1 BOX (17856-0511-2) / 10 mL in 1 CUP72 cup2024-04-100000-00-00NoNoCurrent