NDC codes

FDA NDC Directory
Product NDC (as listed)64616-072Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64616-0072Add 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
64616-072-016461600720164616007201118 mL in 1 BOTTLE (64616-072-01)Marketed from Jul 7, 2010

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)
Formula 3 Cough Syrup
Generic name (nonproprietary)
cough syrup
Active ingredients
Pelargonium sidoides root — 1 [hp_X]/mLPrunus serotina bark — 1 [hp_X]/mLSambucus nigra flower — 1 [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
Identifiers
Product ID 64616-072_462f5bc0-eea2-2be8-e063-6294a90a958dSPL ID 462f5bc0-eea2-2be8-e063-6294a90a958dSPL set ID 199bbe91-ebfe-45fa-acba-62b35c7e6fbaUNII H6J53HEX8E, 5D48E975HA, 07V4DX094TUPC 0608274109506

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

N464616007201 followed by a unit qualifier and the quantity

Package 64616-0072-01. 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 .

Indications (excerpt from the label)

Formula 3 Cough Syrup Temprarily relieves symptoms of cough including dryness and minor throat and bronchial irritation associated with the common cold.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64616-072

What is NDC 64616-072?
64616-072 is the product NDC for Formula 3 Cough Syrup (cough syrup), Pelargonium sidoides root 1 [hp_X]/mL + 2 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?
Formula 3 Cough Syrup (Cough Syrup).
What is the active ingredient?
Pelargonium sidoides root, Prunus serotina bark, Sambucus nigra flower.
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 Formula 3 Cough Syrup?
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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