NDC codes

FDA NDC Directory
Product NDC (as listed)61594-013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61594-0013Add 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
61594-013-0361594001303101 mL in 1 BOTTLE (61594-013-03)Marketed from Jul 11, 2020
61594-013-0761594001307210 mL in 1 BOTTLE (61594-013-07)Marketed from Jul 11, 2020

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

Generic name (nonproprietary)
frankincense
Active ingredients
Frankincense — 8 [hp_X]/210mL
Dosage form
Liquid
Route
Topical
Labeler
AVADIM HOLDINGS, INC.NDC labeler code 61594
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 61594-013_1b2fea8c-49c9-62eb-e063-6394a90adb5eSPL ID 1b2fea8c-49c9-62eb-e063-6394a90adb5eSPL set ID 37c297f6-6b3e-495c-9f72-9327e0638cc5UNII R9XLF1R1WMUPC 0893198002860, 0850005308027

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

N461594001303 followed by a unit qualifier and the quantity

Package 61594-0013-03. 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)

Uses relives joint discomfort increases range of motion improves daily function

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61594-013

What is NDC 61594-013?
61594-013 is the product NDC for Theraworx Relief Joint Discomfort and Inflammation, Frankincense 8 [hp_X]/210mL liquid, listed with the FDA by AVADIM HOLDINGS, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Theraworx Relief Joint Discomfort and Inflammation (Frankincense).
What is the active ingredient?
Frankincense.
Who is the labeler?
AVADIM HOLDINGS, INC., NDC labeler code 61594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Theraworx Relief Joint Discomfort and Inflammation?
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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