FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
63629-1031
11-digit product format
636291031
Labeler code
63629
Product ID
63629-1031_05ce0a40-2603-45c7-a4f4-d8d26c7e7362
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-10-01
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1031DDiscontinued by firm2026-08-11
excluded packagepackage63629-103163629-1031-1DDiscontinued by firm2026-08-11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1031-1Hyoscyamine Sulfate100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1031-1EA - Each63629-10314f994ffa-c119-488d-9c36-bc1a5fd8a92f12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1031HYOSCYAMINE SULFATE TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 1 package rows20230126_5dd29015-ce42-4d61-a6bc-d9b7a23411b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN5dd29015-ce42-4d61-a6bc-d9b7a23411b58
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD5dd29015-ce42-4d61-a6bc-d9b7a23411b58
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY5dd29015-ce42-4d61-a6bc-d9b7a23411b58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1031-163629103101100 TABLET in 1 BOTTLE (63629-1031-1) 100 tablet2022-03-080000-00-00NoNoCurrent