What is NDC 64616-082?

64616-082 is the product NDC for Category I (immune system booster), Actaea spicata root 6 [hp_X]/mL + 11 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 I (Immune System Booster).

What is the active ingredient?

Actaea spicata root, Anagallis arvensis, Argemone mexicana, Candida albicans, Heloderma horridum venom, Hyoscyamus niger, Potassium dichromate, Potassium iodide, Potassium nitrate, Potassium phosphate, Dibasic, Senna leaf, Spongia officinalis skeleton, Roasted.

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 I?

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.

Category I NDC 64616-082 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64616-082Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64616-0082Add 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
64616-082-02	6461600820264616008202	59 mL in 1 BOTTLE, DROPPER (64616-082-02)Marketed from Apr 16, 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 I
Generic name (nonproprietary): immune system booster
Active ingredients: Actaea spicata root — 6 [hp_X]/mLAnagallis arvensis — 6 [hp_X]/mLArgemone mexicana — 15 [hp_X]/mLCandida albicans — 17 [hp_X]/mLHeloderma horridum venom — 14 [hp_X]/mLHyoscyamus niger — 5 [hp_X]/mLPotassium dichromate — 10 [hp_X]/mLPotassium iodide — 10 [hp_X]/mLPotassium nitrate — 10 [hp_X]/mLPotassium phosphate, Dibasic — 10 [hp_X]/mLSenna leaf — 7 [hp_X]/mLSpongia officinalis skeleton, Roasted — 15 [hp_X]/mL
Dosage form: Liquid
Route: Oral
Labeler: Vitality Works, IncNDC labeler code 64616
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Mar 20, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Fungal Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)
Identifiers: Product ID 64616-082_462efc33-321d-a6e4-e063-6294a90abcc5SPL ID 462efc33-321d-a6e4-e063-6294a90abcc5SPL set ID 1cbb330b-b541-457b-9a97-e17a5837d30dUNII 3FU86L9OS0, 46883LR90E, 6X68976407, 4D7G21HDBC, O9M1UQ4YIO, 4WRK2153H3, T4423S18FM, 1C4QK22F9J, RU45X2JN0Z, CI71S98N1Z, AK7JF626KX, 1PIP394IID
Pharmacologic class: Non-Standardized Fungal Allergenic Extract

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

N464616008202 followed by a unit qualifier and the quantity

Package 64616-0082-02. 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 I For the temporary relief of general systemic malise, flu and cold symptoms and achiness.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64616-082

What is NDC 64616-082?: 64616-082 is the product NDC for Category I (immune system booster), Actaea spicata root 6 [hp_X]/mL + 11 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 I (Immune System Booster).
What is the active ingredient?: Actaea spicata root, Anagallis arvensis, Argemone mexicana, Candida albicans, Heloderma horridum venom, Hyoscyamus niger, Potassium dichromate, Potassium iodide, Potassium nitrate, Potassium phosphate, Dibasic, Senna leaf, Spongia officinalis skeleton, Roasted.
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 I?: 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.

Category I (Immune system booster) NDC 64616-082