NDC codes

FDA NDC Directory
Product NDC (as listed)43857-0033Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43857-0033Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
43857-0033-1438570033014385700330130 mL in 1 BOTTLE, DROPPER (43857-0033-1)Marketed from Aug 16, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Gynobalance
Generic name (nonproprietary)
dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone
Active ingredients
Prasterone — 6 [hp_X]/mLEstradiol — 8 [hp_X]/mLPregnenolone — 8 [hp_X]/mLProgesterone — 8 [hp_X]/mLTestosterone — 8 [hp_X]/mL
Dosage form
Liquid
Route
Oral
Labeler
BioActive Nutritional, Inc.NDC labeler code 43857
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone (Chemical structure)
Identifiers
Product ID 43857-0033_0bf415b8-a443-4bbc-87c3-84ebe76d51bcSPL ID 0bf415b8-a443-4bbc-87c3-84ebe76d51bcSPL set ID 61fa6e6e-42f5-4992-87b5-0770218abc8cUNII 459AG36T1B, 4TI98Z838E, 73R90F7MQ8, 4G7DS2Q64Y, 3XMK78S47OUPC 0210184340995
Pharmacologic class
Androgen; Estrogen; Progesterone

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443857003301 followed by a unit qualifier and the quantity

Package 43857-0033-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

USES: For temporary relief of symptoms due to menopausal hot flashes, loss of libido; for enhancing feelings of wellbeing, enhance calcium metabolism, and improving mental clarity.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43857-0033

What is NDC 43857-0033?
43857-0033 is the product NDC for Gynobalance, Prasterone 6 [hp_X]/mL + 4 more ingredients liquid, listed with the FDA by BioActive Nutritional, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gynobalance (Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone).
What is the active ingredient?
Prasterone, Estradiol, Pregnenolone, Progesterone, Testosterone.
Who is the labeler?
BioActive Nutritional, Inc., NDC labeler code 43857. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gynobalance?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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