Hydrate

Product NDC
43857-0198
11-digit product format
438570198
Labeler code
43857
Product ID
43857-0198_f75a0424-48db-41e5-aa5d-10cfa74269a7
Type
HUMAN OTC DRUG
Nonproprietary name
Coffea Tosta, Ginkgo Biloba, Germanium Sesquioxide, Silicea
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-09-11
Substance
COFFEA ARABICA SEED, ROASTED; GERMANIUM SESQUIOXIDE; GINKGO; SILICON DIOXIDE
Active strength
1; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrate
Brand name suffix
I
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COFFEA ARABICA SEED, ROASTED1 [hp_X]/mL
GERMANIUM SESQUIOXIDE8 [hp_X]/mL
GINKGO6 [hp_X]/mL
SILICON DIOXIDE8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9H58JRT35E, 96WE91N25T, 19FUJ2C58T, ETJ7Z6XBU4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0198-12024-10-17C16284748780-1f386c649-b9f8-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0198-12023-01-30C16284748780-1f386c649-b9f8-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0198-1HydrateI60 mL in 1 BOTTLE, DROPPERLIQUID605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0198HYDRATE I (COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20241019_c0c8d350-0257-4484-acd8-f852350173db.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0198-14385701980160 mL in 1 BOTTLE, DROPPER (43857-0198-1) 60 ml2016-11-080000-00-00NoNoCurrent