NDC codes

FDA NDC Directory
Product NDC (as listed)64616-069Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64616-0069Add 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
64616-069-0264616006902646160069021 BOTTLE, PLASTIC in 1 CARTON (64616-069-02) / 30 mL in 1 BOTTLE, PLASTIC (64616-069-01)Marketed from Apr 20, 2011

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)
Olive Leaf Acne Remedy
Generic name (nonproprietary)
topical skin relief
Active ingredients
Antimony trisulfide — 12 [hp_X]/mLCalcium sulfate anhydrous — 12 [hp_X]/mLJuglans regia flowering top — 6 [hp_X]/mLSulfur iodide — 30 [hp_X]/mL
Dosage form
Liquid
Route
Topical
Labeler
Vitality Works, IncNDC labeler code 64616
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Other FDA classes
Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
Identifiers
Product ID 64616-069_462ef671-8e94-9d8a-e063-6294a90ab347SPL ID 462ef671-8e94-9d8a-e063-6294a90ab347SPL set ID ca137d01-9feb-446a-8410-3d553e54ee50UNII F79059A38U, E934B3V59H, 3BA2N709NG, L6L8KA2AA0UPC 0019277000675
Pharmacologic class
Blood Coagulation Factor; Phosphate Binder

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N464616006902 followed by a unit qualifier and the quantity

Package 64616-0069-02. 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)

Olive Leaf Acne Remedy For the temporary relief of symptoms of acne, pimples, and cold sores. For the temporary relief of eczema, burning and itching, and skin pustular eruptions.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64616-069

What is NDC 64616-069?
64616-069 is the product NDC for Olive Leaf Acne Remedy (topical skin relief), Antimony trisulfide 12 [hp_X]/mL + 3 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?
Olive Leaf Acne Remedy (Topical Skin Relief).
What is the active ingredient?
Antimony trisulfide, Calcium sulfate anhydrous, Juglans regia flowering top, Sulfur iodide.
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 Olive Leaf Acne Remedy?
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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