Androbalance

Product NDC
43857-0284
11-digit product format
438570284
Labeler code
43857
Product ID
43857-0284_0900ddef-63ec-4d5f-aa9d-10e023191a02
Type
HUMAN OTC DRUG
Nonproprietary name
DHEA (Dehydroepiandrosterone) Pregnenolone, Progesterone, Testosterone
Dosage form
SPRAY
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-02-24
Substance
PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE
Active strength
6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Progesterone [CS], Progesterone [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRASTERONE6 [hp_X]/mL
PREGNENOLONE8 [hp_X]/mL
PROGESTERONE8 [hp_X]/mL
TESTOSTERONE8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459AG36T1B, 73R90F7MQ8, 4G7DS2Q64Y, 3XMK78S47O

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0284-12023-06-05C16284748780-19d75b9cf-fe75-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0284-12023-01-30C16284748780-19d75b9cf-fe75-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0284-12021-07-28C16284748780-19d75b9cf-fe75-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0284-12020-01-31C16284748780-19d75b9cf-fe75-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0284-1Androbalance30 mL in 1 BOTTLE, SPRAYSPRAY305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRASTERONEACTIVE INGREDIENT459AG36T1BANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PREGNENOLONEACTIVE INGREDIENT73R90F7MQ8ANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PROGESTERONEACTIVE INGREDIENT4G7DS2Q64YANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PRASTERONEACTIVE MOIETY459AG36T1BANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PREGNENOLONEACTIVE MOIETY73R90F7MQ8ANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PROGESTERONEACTIVE MOIETY4G7DS2Q64YANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0284ANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20230607_e231695a-165a-419e-b594-34f9522503ac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0284-14385702840130 mL in 1 BOTTLE, SPRAY (43857-0284-1) 30 ml2017-04-130000-00-00NoNoCurrent