Category IV (immune system booster) NDC 64616-085

NDC codes

FDA NDC Directory

Product NDC (as listed)64616-085Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64616-0085Add 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 NDC	11-digit (billing)	Package	Copy
64616-085-02	64616008502	59 mL in 1 BOTTLE, DROPPER (64616-085-02)Marketed from Mar 20, 2013

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Category IV
Generic name (nonproprietary): immune system booster
Active ingredients: Actaea spicata root — 6 [hp_X]/mLAloe — 7 [hp_X]/mLLytta vesicatoria — 7 [hp_X]/mLCupric arsenite — 15 [hp_X]/mLCopper — 10 [hp_X]/mLSolanum dulcamara top — 5 [hp_X]/mLSkim milk — 20 [hp_X]/mLFraxinus americana bark — 8 [hp_X]/mLUrtica urens — 5 [hp_X]/mLZinc — 20 [hp_X]/mL
Dosage form: Liquid
Route: Oral
Labeler: Vitality Works, Inc.
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Mar 20, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Copper (Chemical structure)Decreased Embryonic Implantation (Physiologic effect)Decreased Sperm Motility (Physiologic effect)Inhibit Ovum Fertilization (Physiologic effect)
Identifiers: Product ID 64616-085_462efdaf-fea9-a564-e063-6294a90aeaf6SPL ID 462efdaf-fea9-a564-e063-6294a90aeaf6SPL set ID 790a1b3e-2b5e-426c-9c43-8674c59c9ce1UNII 3FU86L9OS0, V5VD430YW9, 3Q034RO3BT, SK8L60BCSQ, 789U1901C5, KPS1B1162N, 6A001Y4M5A, 0B24UR1O1S, IHN2NQ5OF9, J41CSQ7QDS
Pharmacologic class: Copper-containing Intrauterine Device

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

N464616008502 followed by a unit qualifier and the quantity

Package 64616-0085-02. 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 Dec 17, 2025.

Indications (excerpt from the label)

Category IV For the temporary relief of headaches, malaise, fever, digestive upset and discomfort, sleeplessness and general unrest.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)