NDC codes

FDA NDC Directory
Product NDC (as listed)61594-021Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61594-0021Add 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
61594-021-006159400210061594002100101 mL in 1 BOTTLE (61594-021-00)Marketed from Feb 1, 2022

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)
magnesium sulfate, unspecified form
Active ingredients
Magnesium sulfate, Unspecified form — 6 [hp_X]/mL
Dosage form
Aerosol, Foam
Route
Topical
Labeler
AVADIM HOLDINGS, INC.NDC labeler code 61594
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Other FDA classes
Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 61594-021_fa2372ee-b30f-9ddd-e053-6394a90af5b9SPL ID fa2372ee-b30f-9ddd-e053-6394a90af5b9SPL set ID 2f7fe6b7-deb0-4bf7-a8cb-15ae468512daUNII DE08037SABUPC 0850005308850
Pharmacologic class
Calculi Dissolution Agent; Osmotic Laxative

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

N461594002100 followed by a unit qualifier and the quantity

Package 61594-0021-00. 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 prevents cramps and spasms releases muscle tightness relieves muscle sorenss

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61594-021

What is NDC 61594-021?
61594-021 is the product NDC for Theraworx Relief for Foot Cramps Foam, Magnesium sulfate, Unspecified form 6 [hp_X]/mL aerosol, foam, listed with the FDA by AVADIM HOLDINGS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Theraworx Relief for Foot Cramps Foam (Magnesium sulfate, Unspecified form).
What is the active ingredient?
Magnesium sulfate, Unspecified form.
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 for Foot Cramps Foam?
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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