FDA.reportPublic FDA data

apo-ENTERIT

Product NDC
59469-158
11-digit product format
594690158
Labeler code
59469
Product ID
59469-158_ea8d652c-1583-4429-9d09-928b215a9275
Type
HUMAN OTC DRUG
Nonproprietary name
Citrullus colocynthis Fruit Pulp, Podophyllum, Veratrum album Root, Artemisia abrotanum Flowering Top, Cynara scolymus Whole, and Potentilla anserina Flowering Top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-04-12
Substance
ARTEMISIA ABROTANUM FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; CYNARA SCOLYMUS WHOLE; PODOPHYLLUM; POTENTILLA ANSERINA FLOWERING TOP; VERATRUM ALBUM ROOT
Active strength
760; 4; 2137; 4; 1092; 4 mg/50mL; [hp_X]/50mL; mg/50mL; [hp_X]/50mL; mg/50mL; [hp_X]/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRULLUS COLOCYNTHIS FRUIT PULP760 mg/50mL
PODOPHYLLUM4 [hp_X]/50mL
VERATRUM ALBUM ROOT2137 mg/50mL
ARTEMISIA ABROTANUM FLOWERING TOP4 [hp_X]/50mL
CYNARA SCOLYMUS WHOLE1092 mg/50mL
POTENTILLA ANSERINA FLOWERING TOP4 [hp_X]/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii23H32AOH17, 2S713A4VP3, QNS6W5US1Z, QG07G580U0, 9N3437ZUU0, H00Y243SK0

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-158-10apo-ENTERIT1 in 1 BOXSOLUTION/ DROPS15
59469-158-10apo-ENTERIT50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-158APO-ENTERIT (CITRULLUS COLOCYNTHIS FRUIT PULP, PODOPHYLLUM, VERATRUM ALBUM ROOT, ARTEMISIA ABROTANUM FLOWERING TOP, CYNARA SCOLYMUS WHOLE, AND POTENTILLA ANSERINA FLOWERING TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 2 package rows20221206_0c2efd18-2f1e-4bb3-99e2-b9752db16626.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-158-10594690158101 BOTTLE, GLASS in 1 BOX (59469-158-10) / 50 mL in 1 BOTTLE, GLASS2008-04-120000-00-00NoNoCurrent