Histatone NDC 44911-0580

NDC codes

FDA NDC Directory

Product NDC (as listed)44911-0580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44911-0580Add 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
44911-0580-1	44911058001	30 mL in 1 BOTTLE, DROPPER (44911-0580-1)Marketed from May 25, 2021

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): Histatone
Generic name (nonproprietary): allium sativum, baptisia tinctoria, echinacea (angustifolia), allium cepa, ambrosia artemisiaefolia, arsenicum album, phosphorus, pulsatilla (pratensis), solidago virgaurea
Active ingredients: Garlic — 3 [hp_X]/mLBaptisia tinctoria root — 3 [hp_X]/mLEchinacea angustifolia whole — 3 [hp_X]/mLOnion — 12 [hp_X]/mLAmbrosia artemisiifolia whole — 12 [hp_X]/mLArsenic trioxide — 12 [hp_X]/mLPhosphorus — 12 [hp_X]/mLPulsatilla pratensis whole — 12 [hp_X]/mLSolidago virgaurea flowering top — 12 [hp_X]/mL
Dosage form: Liquid
Route: Oral
Labeler: Energique, Inc.
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: May 25, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Dietary Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Plant Proteins (Chemical structure)Vegetable Proteins (Chemical structure)
Identifiers: Product ID 44911-0580_d701f94c-3c2d-421e-89ed-58237b458e95SPL ID d701f94c-3c2d-421e-89ed-58237b458e95SPL set ID 309fe946-8639-4c17-a939-06bffe6caa2dUNII V1V998DC17, 5EF0HWI5WU, VB06AV5US8, 492225Q21H, 9W34L2CQ9A, S7V92P67HO, 27YLU75U4W, 8E272251DI, 5405K23S50UPC 0363113701227
Pharmacologic class: Non-Standardized Food 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

N444911058001 followed by a unit qualifier and the quantity

Package 44911-0580-01. 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 Oct 25, 2024.

Indications (excerpt from the label)

INDICATIONS: For temporary relief of hay fever, sinus, cough, bronchial irritation, itching and burning.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)