FDA.reportPublic FDA data

Hepapar

Product NDC
44911-0516
11-digit product format
449110516
Labeler code
44911
Product ID
44911-0516_8d8552df-3dfa-45ee-a686-94593c464dcf
Type
HUMAN OTC DRUG
Nonproprietary name
Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Boldo, Hepar Suis, Lycopodium Clavatum, Mercurius Solubilis, Natrum Sulphuricum, Nux Vomica, Phosphorus, Chenopodium Anthelminticum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-25
Marketing end
2027-08-02
Substance
CHELIDONIUM MAJUS WHOLE; DYSPHANIA AMBROSIOIDES WHOLE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; MILK THISTLE; PEUMUS BOLDUS LEAF; PHOSPHORUS; PORK LIVER; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE
Active strength
3; 16; 12; 12; 3; 6; 12; 6; 12; 12; 3 [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; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hepapar

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
DYSPHANIA AMBROSIOIDES WHOLE16 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
MILK THISTLE3 [hp_X]/mL
PEUMUS BOLDUS LEAF6 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PORK LIVER6 [hp_X]/mL
SODIUM SULFATE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7E889U5RNN, 4H5RSU087I, C88X29Y479, 324Y4038G2, U946SH95EE, Q4EWM09M3O, 27YLU75U4W, 6EC706HI7F, 0YPR65R21J, 269XH13919, 39981FM375

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0516-12024-08-26C16284748780-1ba0f9c33-2938-a910-e053-dadaa90a0b85Drug Facts:
44911-0516-12024-01-30C16284748780-1ba0f9c33-2938-a910-e053-dadaa90a0b85Drug Facts:
44911-0516-12022-03-09C16284748780-1ba0f9c33-2938-a910-e053-dadaa90a0b85Drug Facts:
44911-0516-12021-01-29C16284748780-1ba0f9c33-2938-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0516-1Hepapar30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0516HEPAPAR (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, BOLDO, HEPAR SUIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, CHENOPODIUM ANTHELMINTICUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240828_9c670a50-16db-42a4-bc29-02818e27ea85.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0516-14491105160130 mL in 1 BOTTLE, DROPPER (44911-0516-1) 30 ml2019-10-252027-08-02NoNoCurrent