Hyoscyamine

Product NDC
75929-057
11-digit product format
759290057
Labeler code
75929
Product ID
75929-057_347830a8-8833-26b7-e063-6294a90a1f17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Pharma Packaging Solutions, LLC dba Tjopack LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-05-01
Substance
HYOSCYAMINE SULFATE
Active strength
.375 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046770

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75929-057-10HyoscyamineER100 in 1 BOTTLETABLET, EXTENDED RELEASE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75929-057HYOSCYAMINE ER (HYOSCYAMINE SULFATE) TABLET, EXTENDED RELEASE [PHARMA PACKAGING SOLUTIONS, LLC DBA TJOPACK LLC]3Current NDC, 1 package rows20250507_01f97804-a6cb-ce6d-e063-6394a90ae220.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046770hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral TabletPSN01f97804-a6cb-ce6d-e063-6394a90ae2203
104677012 HR hyoscyamine sulfate 0.375 MG Extended Release Oral TabletSCD01f97804-a6cb-ce6d-e063-6394a90ae2203
1046770hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral TabletSY01f97804-a6cb-ce6d-e063-6394a90ae2203
1046770hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral TabletSY01f97804-a6cb-ce6d-e063-6394a90ae2203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75929-057-1075929005710100 TABLET, EXTENDED RELEASE in 1 BOTTLE (75929-057-10) 2016-05-01NoNoCurrent