Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Androbalance NDC 43857-0284
dhea (dehydroepiandrosterone) pregnenolone, progesterone, testosterone · Prasterone 6 [hp_X]/mL + 3 more ingredients · Spray · Oral · BioActive Nutritional, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43857-0284-1 | 43857028401 | 30 mL in 1 BOTTLE, SPRAY (43857-0284-1)Marketed from Apr 13, 2017 |
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)
- Androbalance
- Generic name (nonproprietary)
- dhea (dehydroepiandrosterone) pregnenolone, progesterone, testosterone
- Active ingredients
- Prasterone — 6 [hp_X]/mLPregnenolone — 8 [hp_X]/mLProgesterone — 8 [hp_X]/mLTestosterone — 8 [hp_X]/mL
- Dosage form
- Spray
- Route
- Oral
- Labeler
- BioActive Nutritional, Inc.
- 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)Progesterone (Chemical structure)
- Identifiers
- Product ID 43857-0284_0900ddef-63ec-4d5f-aa9d-10e023191a02SPL ID 0900ddef-63ec-4d5f-aa9d-10e023191a02SPL set ID e231695a-165a-419e-b594-34f9522503acUNII 459AG36T1B, 73R90F7MQ8, 4G7DS2Q64Y, 3XMK78S47O
- Pharmacologic class
- Androgen; 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
N443857028401followed by a unit qualifier and the quantityPackage 43857-0284-01. 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 male andropause such as: lethargy, muscle weakness & aches, and decrease in libido.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Excerpt only. Read the full label for complete information.