Home NDC 17856-0514 Hyosyne
Product NDC 17856-0514
11-digit product format 178560514
Labeler code 17856
Product ID 17856-0514_34f474e7-be30-bf9e-e063-6294a90a9b9a
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0514-5 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-0514-5 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 17856-0514-5 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 17856-0514-5 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base Hyosyne
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYOSCYAMINE SULFATE .125 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F2R8V82B84 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1047881 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0514-5 Hyosyne 5 mL in 1 CUP ELIXIR 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0514 HYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [ATLANTIC BIOLOGICALS CORP.] 5 Current NDC, Legacy NDC, 1 package rows 20250514_08ee0b24-a05b-451c-9d29-975570baed48.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hyosyne HYOSCYAMINE SULFATE ATLANTIC BIOLOGICALS CORP. 08ee0b24-a05b-451c-9d29-975570baed48 2025-05-12 Warnings, Adverse reactions Exact identifier ndc (product): 17856-0514
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17856-0514-5 17856051405 5 mL in 1 CUP (17856-0514-5) 5 ml 2024-04-12 0000-00-00 No No Current