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 NDC11-digit (billing)PackageCopy
64616-085-02646160085026461600850259 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.NDC labeler code 64616
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
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 .

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)

About NDC 64616-085

What is NDC 64616-085?
64616-085 is the product NDC for Category IV (immune system booster), Actaea spicata root 6 [hp_X]/mL + 9 more ingredients liquid, listed with the FDA by Vitality Works, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Category IV (Immune System Booster).
What is the active ingredient?
Actaea spicata root, Aloe, Lytta vesicatoria, Cupric arsenite, Copper, Solanum dulcamara top, Skim milk, Fraxinus americana bark, Urtica urens, Zinc.
Who is the labeler?
Vitality Works, Inc., NDC labeler code 64616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Category IV?
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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