gynobalance

Generic: dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone

Labeler: bioactive nutritional, inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name gynobalance
Generic Name dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone
Labeler bioactive nutritional, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

estradiol 8 [hp_X]/mL, prasterone 6 [hp_X]/mL, pregnenolone 8 [hp_X]/mL, progesterone 8 [hp_X]/mL, testosterone 8 [hp_X]/mL

Manufacturer
BioActive Nutritional, Inc.

Identifiers & Regulatory

Product NDC 43857-0033
Product ID 43857-0033_24deb803-ab80-49ec-81e5-4ef5ce24fcf5
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2013-01-18

Pharmacologic Class

Established (EPC)
estrogen [epc] progesterone [epc] androgen [epc]
Mechanism of Action
estrogen receptor agonists [moa] androgen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs] progesterone [cs] androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 438570033
Hyphenated Format 43857-0033

Supplemental Identifiers

UNII
4TI98Z838E 459AG36T1B 73R90F7MQ8 4G7DS2Q64Y 3XMK78S47O
NUI
M0447348 N0000175825 N0000000100 M0017672 N0000175601 N0000175824 N0000000146 M0001109

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gynobalance (source: ndc)
Generic Name dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 [hp_X]/mL
  • 6 [hp_X]/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (43857-0033-1)
source: ndc

Packages (1)

43857-0033-1 30 mL in 1 BOTTLE, DROPPER (43857-0033-1)

Ingredients (5)

estradiol (8 [hp_X]/mL) prasterone (6 [hp_X]/mL) pregnenolone (8 [hp_X]/mL) progesterone (8 [hp_X]/mL) testosterone (8 [hp_X]/mL)

Linked Drug Pages (1)

Gynobalance ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24deb803-ab80-49ec-81e5-4ef5ce24fcf5", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100", "M0017672", "N0000175601", "N0000175824", "N0000000146", "M0001109"], "unii": ["4TI98Z838E", "459AG36T1B", "73R90F7MQ8", "4G7DS2Q64Y", "3XMK78S47O"], "spl_set_id": ["61fa6e6e-42f5-4992-87b5-0770218abc8c"], "pharm_class_cs": ["Estradiol Congeners [CS]", "Progesterone [CS]", "Androstanes [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progesterone [EPC]", "Androgen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]", "Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["BioActive Nutritional, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, DROPPER (43857-0033-1)", "package_ndc": "43857-0033-1", "marketing_start_date": "20160816"}], "brand_name": "Gynobalance", "product_id": "43857-0033_24deb803-ab80-49ec-81e5-4ef5ce24fcf5", "dosage_form": "LIQUID", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]", "Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone [CS]", "Progesterone [EPC]"], "product_ndc": "43857-0033", "dea_schedule": "CIII", "generic_name": "Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone", "labeler_name": "BioActive Nutritional, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gynobalance", "active_ingredients": [{"name": "ESTRADIOL", "strength": "8 [hp_X]/mL"}, {"name": "PRASTERONE", "strength": "6 [hp_X]/mL"}, {"name": "PREGNENOLONE", "strength": "8 [hp_X]/mL"}, {"name": "PROGESTERONE", "strength": "8 [hp_X]/mL"}, {"name": "TESTOSTERONE", "strength": "8 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20130118", "listing_expiration_date": "20261231"}