apo-HEPAT

Product NDC
59469-106
11-digit product format
594690106
Labeler code
59469
Product ID
59469-106_5f7e7812-2809-4491-9306-d5452a65d788
Type
HUMAN OTC DRUG
Nonproprietary name
Chionanthus virginicus Bark, Iberis amara Seed, Lycopodium clavatum Spore, Mandragora officinarum Root, Phosphorus, Peumus boldus Leaf, Cynara scolymus Whole, and Taraxacum officinale Whole
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-04-12
Substance
CHIONANTHUS VIRGINICUS ROOT BARK; IBERIS AMARA SEED; LYCOPODIUM CLAVATUM SPORE; MANDRAGORA OFFICINARUM ROOT; PHOSPHORUS; PEUMUS BOLDUS LEAF; CYNARA SCOLYMUS WHOLE; TARAXACUM OFFICINALE WHOLE
Active strength
2; 6; 4; 12; 10; 6; 8; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHIONANTHUS VIRGINICUS ROOT BARK2 [hp_X]/50mL
IBERIS AMARA SEED6 [hp_X]/50mL
LYCOPODIUM CLAVATUM SPORE4 [hp_X]/50mL
MANDRAGORA OFFICINARUM ROOT12 [hp_X]/50mL
PHOSPHORUS10 [hp_X]/50mL
PEUMUS BOLDUS LEAF6 [hp_X]/50mL
CYNARA SCOLYMUS WHOLE8 [hp_X]/50mL
TARAXACUM OFFICINALE WHOLE8 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S9Y4B22U2EInternal UNII lookup
T90A7M66YFInternal UNII lookup
C88X29Y479Internal UNII lookup
I2XCB174VBInternal UNII lookup
27YLU75U4WInternal UNII lookup
Q4EWM09M3OInternal UNII lookup
9N3437ZUU0Internal UNII lookup
7C42E2D7B0Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ad32e27-b0a2-43e9-b306-2ebafc5adf83Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-106-10apo-HEPAT50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505
59469-106-10apo-HEPAT1 in 1 BOXSOLUTION/ DROPS15
59469-106-40apo-HEPAT1 in 1 BOXSOLUTION/ DROPS15
59469-106-40apo-HEPAT100 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-106APO-HEPAT (CHIONANTHUS VIRGINICUS BARK, IBERIS AMARA SEED, LYCOPODIUM CLAVATUM SPORE, MANDRAGORA OFFICINARUM ROOT, PHOSPHORUS, PEUMUS BOLDUS LEAF, CYNARA SCOLYMUS WHOLE, AND TARAXACUM OFFICINALE WHOLE) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 4 package rows20221206_7ad32e27-b0a2-43e9-b306-2ebafc5adf83.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
apo-HEPATCHIONANTHUS VIRGINICUS BARK, IBERIS AMARA SEED, LYCOPODIUM CLAVATUM SPORE, MANDRAGORA OFFICINARUM ROOT, PHOSPHORUS, PEUMUS BOLDUS LEAF, CYNARA SCOLYMUS WHOLE, AND TARAXACUM OFFICINALE WHOLEPEKANA Naturheilmittel GmbH7ad32e27-b0a2-43e9-b306-2ebafc5adf832022-12-02WarningsExact identifier
ndc (product): 59469-106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-106-10594690106101 BOTTLE, GLASS in 1 BOX (59469-106-10) / 50 mL in 1 BOTTLE, GLASS2008-12-040000-00-00NoNoCurrent
59469-106-40594690106401 BOTTLE, GLASS in 1 BOX (59469-106-40) / 100 mL in 1 BOTTLE, GLASS2008-12-040000-00-00NoNoCurrent