NDC 63479-0109-01 — A09 FEMALE BALANCE ARGENTUM NITRICUM

🆔 Identity & classification

FDA NDC (as labeled) 63479-0109-1

Product NDC 63479-0109

11-digit billing NDC 63479010901

UNII Z5BEX9K2G1, 92AMN5J79Y, 706IDJ14B7, 0B4FDL9I6P, 66LZN1C747, 1M529TNT1D +12 more

SPL Set ID b8e1ba2a-f80f-158e-e053-2a95a90aacd1

Established class (EPC) Progesterone

Chemical class Progesterone

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1988-08-15

Route SUBLINGUAL

Dosage form SOLUTION/ DROPS

Substance JUNIPERUS SABINA LEAFY TWIG; SUS SCROFA SPLEEN; ALLYLTHIOUREA; THYROID, UNSPECIFIED; BOS TAURUS OVARY; BOS TAURUS PANCREAS; SILVER NITRATE; ESTRONE; SEPIA OFFICINALIS JUICE; SUS SCROFA PINEAL GLAND; CHAMAELIRIUM LUTEUM ROOT; PROGESTERONE; SEQUOIADENDRON G

Why two NDCs? The FDA registers this code as 63479-0109-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 63479-0109-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerApex Energetics Inc.

Labeler code63479

First marketedAug 1988

Product typeHuman Otc Drug

Portfolio110 products on file

🔎 All NDCs from Apex Energetics Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an unapproved homeopathic liquid product taken as drops under the tongue. It contains plant extracts (black cohosh, pulsatilla, and sepia), animal-derived substances (bovine ovary, pancreas, pituitary, and uterus), and hormones (estrone and progesterone) that are traditionally used in homeopathic practice for symptoms related to female reproductive health and hormonal balance. Homeopathic products are marketed based on traditional use and are not evaluated by the FDA for effectiveness or safety.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesalcohol (20% by volume), distilled water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
A09 Female Balance 12 [hp_X]/mL; 7 [hp_C]/mL; 8 [hp_X]/mL; 7 [hp_C]/mL; 7 [hp_C]/mL; 7 [hp_C]/mL; 9 [hp_X]/mL; 9 [hp_C]/mLthis 63479-0109-01	Apex	30 ml	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

1988

On the market since

Aug 1988

📍

2026

Currently FDA-listed

38 years listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
63479-0109-01 You're viewing this	30 mL in 1 BOTTLE, GLASS (63479-0109-1)	1988-08-15	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

A09 FEMALE BALANCE ARGENTUM NITRICUM, ATROPINUM SULPHURICUM, AURUM MURIATICUM NATRONATUM, BOS TAURUS OVARY, BOS TAURUS PANCREAS, BOS TAURUS PITUITARUM POSTERIUM, BOS TAURUS UTERUS, CIMICIFUGA RACEMOSA, ESTRONE, HELONIAS DIOICA, PROGESTERONE, PULSATILLA VULGARIS, SABINA, SEP 12 [hp_X]/mL; 7 [hp_C]/mL; 8 [hp_X]/mL; 7 [hp_C]/mL; 7 [hp_C]/mL; 7 [hp_C]/mL; 9 [hp_X]/mL; 9 [hp_C]/mL SOLUTION/ DROPS is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 63479-0109-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63479-0109-01, written without dashes as 63479010901. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 63479-0109-01, the first segment (63479) is the labeler code FDA assigned to Apex Energetics Inc.; the middle segment (0109) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Apex Energetics Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Apex Energetics Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 35 words ▾

Uses: For temporary relief of minor: • menstrual irregularity* • headache* • fatigue* • menstrual cramps* • backache during menstruation* • irritability* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

⏱️ Dosage and Administration 37 words ▾

Adults & children ages 12 years and over: Take 10 drops under the tongue 2-3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

⚠️ Warnings 77 words ▾

Warnings: If pregnant or breastfeeding , ask a health professional before use. Do not use if clear seal over the cap is broken or missing. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if menstrual irregularity, headche, fatigue, menstrual cramps, backache during menstruation, irritability, or other symptoms do not improve within 7 days or are accompanied by fever.

🧪 Active Ingredient 103 words ▾

Active Ingredients Argentum Nitricum 6X 8X 9X Atropinum Sulphuricum 6X 8X 10X Aurum Muriaticum Natronatum 4X 6X 8X 10X 12X Bos Taurus Ovary 4C 7C Bos Taurus Pancreas 4C 7C Bos Taurus Pituitarum Posterium 4C 7C 9C Bos Taurus Uterus 7C Cimicifuga Racemosa 6X 8X 10X Estrone 4C 7C 9C Helonias Dioica 4X 6X 8X Progesterone 4C 7C 9C Pulsatilla Vulgaris 4C 6C 8C 10C Sabina 6X 9X 12X Sepia 9X 12X 15X 30X Sequoiadendron Giganteum Whole 3X 6X 9X Sus Scrofa Pineal Gland 4C 7C 9C Sus Scrofa Spleen 4C 7C Thiosinaminum 6X 8X Thyroidinum 4C 7C Viburnum Opulus 4X 6X 8X

🧪 Inactive Ingredients 6 words ▾

alcohol (20% by volume), distilled water

🎯 Purpose 35 words ▾

Uses: For temporary relief of minor: • menstrual irregularity* • headache* • fatigue* • menstrual cramps* • backache during menstruation* • irritability* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Argentum Nitricum, Atropinum Sulphuricum, Aurum Muriaticum Natronatum, Bos Taurus Ovary, Bos Taurus Pancreas, Bos Taurus Pituitarum Posterium, Bos Taurus Uterus, Cimicifuga Racemosa, Estrone, Helonias Dioica, Progesterone, Pulsatilla Vulgaris, Sabina, Sep NDCsSame ingredient 🏭 All Apex labeler NDCsLabeler code 63479 📚 All Anticholinergic NDCsDrug class