hyoscyamine sulfate

Product NDC
47781-014
11-digit product format
477810014
Labeler code
47781
Product ID
47781-014_b60f77c1-53a5-3a04-c356-dcc368dfc850
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-01-31
Marketing end
0000-00-00
Substance
HYOSCYAMINE SULFATE
Active strength
0 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct47781-014DDiscontinued by firm2026-08-11
excluded packagepackage47781-01447781-014-01DDiscontinued 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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct47781-014DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage47781-01447781-014-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-014-01EA - Each47781-014c40256b4-e677-47c9-9413-2109fc75c48a12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-014HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE [ALVOGEN INC.]3Legacy NDC20240510_d02d1b0d-5c40-c5aa-b283-74efd7d1e06b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-014-0147781001401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-014-01) 2022-01-310000-00-00NoNoCurrent