Hyoscyamus Niger

Product NDC
53645-1500
11-digit product format
536451500
Labeler code
53645
Product ID
53645-1500_faa4af8f-b8fa-98a8-e053-6394a90ac9f7
Type
HUMAN OTC DRUG
Nonproprietary name
Hyoscyamus Niger
Dosage form
GLOBULE
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-02-03
Substance
HYOSCYAMUS NIGER
Active strength
30 [hp_X]/23g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamus Niger
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMUS NIGER30 [hp_X]/23g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4WRK2153H3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53645-1500-22021-01-31C16284748780-1ba0f9c33-3fa2-a910-e053-dadaa90a0b85Hyoscyamus Niger 30X
53645-1500-22021-01-29C16284748780-1ba0f9c33-3fa2-a910-e053-dadaa90a0b85Hyoscyamus Niger 30X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-1500-2Hyoscyamus Niger23 g in 1 BOTTLEGLOBULE235

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1500HYOSCYAMUS NIGER GLOBULE [TRUE BOTANICA, LLC]5Current NDC, Legacy NDC, 1 package rows20230502_6195633c-839c-228b-e053-2a91aa0aecdf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1500-25364515000223 g in 1 BOTTLE (53645-1500-2) 23 g2014-02-030000-00-00NoNoCurrent