Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Gynobalance NDC 43857-0033
dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone · Prasterone 6 [hp_X]/mL + 4 more ingredients · Liquid · Oral · BioActive Nutritional, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43857-0033-1 | 4385700330143857003301 | 30 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
N443857003301followed by a unit qualifier and the quantityPackage 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.
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.