Systemistat

Product NDC
44911-0449
11-digit product format
449110449
Labeler code
44911
Product ID
44911-0449_babfa6e6-4ea6-4937-af61-795cc3cb257e
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis Vulgaris, Chelidonium Majus, Lappa Major, Hydrastis Canadensis, Hepar Sulphuris Calcareum, Lycopodium Clavatum, Sulphur, Calcarea Carbonica, Mercurius Solubilis, Thuja Occidentalis
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-03-06
Substance
ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CHELIDONIUM MAJUS WHOLE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG
Active strength
3; 3; 12; 3; 5; 12; 30; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTIUM LAPPA ROOT3 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
CALCIUM SULFIDE12 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
GOLDENSEAL5 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
MERCURIUS SOLUBILIS30 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]/mL
SULFUR12 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii597E9BI3Z3, 1TH8Q20J0U, 1MBW07J51Q, 7E889U5RNN, ZW3Z11D0JV, C88X29Y479, 324Y4038G2, 2E32821G6I, 70FD1KFU70, 1NT28V9397

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0449-12022-03-15C16284748780-1d6a99b39-fa03-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0449-12022-01-28C16284748780-1d6a99b39-fa03-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0449-1Systemistat30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0449SYSTEMISTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20230422_0d8aa575-3fae-4828-8827-d2561672a91e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0449-14491104490130 mL in 1 BOTTLE, DROPPER (44911-0449-1) 30 ml2018-03-060000-00-00NoNoCurrent