Genstat

Product NDC
44911-0520
11-digit product format
449110520
Labeler code
44911
Product ID
44911-0520_aacaa774-0e0d-49da-85f0-023aeb49f339
Type
HUMAN OTC DRUG
Nonproprietary name
Aesculus Hippocastanum, Equisetum Hyemale, Fumaria Officinalis, Hydrocotyle Asiatica, Oleum Olea Europaea, Passiflora Incarnata, Ribes Nigrum, Solidago Virgaurea, Ononis Spinosa
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-25
Substance
CENTELLA ASIATICA WHOLE; EQUISETUM HYEMALE WHOLE; FUMARIA OFFICINALIS FLOWERING TOP; HORSE CHESTNUT; OLIVE OIL; ONONIS SPINOSA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; RIBES NIGRUM LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
6; 6; 6; 6; 6; 14; 6; 7; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Lipid Emulsion [EPC], Lipids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CENTELLA ASIATICA WHOLE6 [hp_X]/mL
EQUISETUM HYEMALE WHOLE6 [hp_X]/mL
FUMARIA OFFICINALIS FLOWERING TOP6 [hp_X]/mL
HORSE CHESTNUT6 [hp_X]/mL
OLIVE OIL6 [hp_X]/mL
ONONIS SPINOSA WHOLE14 [hp_C]/mL
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/mL
RIBES NIGRUM LEAF7 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7M867G6T1U, 59677RXH25, VH659J61ZL, 3C18L6RJAZ, 6UYK2W1W1E, RP8496915M, CLF5YFS11O, Z46FSZ2M25, 5405K23S50

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0520-12023-07-12C16284748780-1ba0f9c33-2935-a910-e053-dadaa90a0b85Drug Facts:
44911-0520-12023-01-30C16284748780-1ba0f9c33-2935-a910-e053-dadaa90a0b85Drug Facts:
44911-0520-12021-05-25C16284748780-1ba0f9c33-2935-a910-e053-dadaa90a0b85Drug Facts:
44911-0520-12021-01-29C16284748780-1ba0f9c33-2935-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0520-1Genstat120 mL in 1 BOTTLE, DROPPERLIQUID1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0520GENSTAT (AESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, HYDROCOTYLE ASIATICA, OLEUM OLEA EUROPAEA, PASSIFLORA INCARNATA, RIBES NIGRUM, SOLIDAGO VIRGAUREA, ONONIS SPINOSA) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20230713_492f311e-f4b5-442d-adc3-d022e58b185e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0520-144911052001120 mL in 1 BOTTLE, DROPPER (44911-0520-1) 120 ml2019-10-250000-00-00NoNoCurrent