NDC codes

FDA NDC Directory
Product NDC (as listed)61594-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61594-0003Add 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
61594-003-006159400030061594000300210 mL in 1 BOTTLE (61594-003-00)Marketed from Jul 22, 2017

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 heptahydrate
Active ingredients
Magnesium sulfate heptahydrate — 6 [hp_X]/210mL
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 61594-003_1c333cca-11d4-3dc8-e063-6394a90a0ba8SPL ID 1c333cca-11d4-3dc8-e063-6394a90a0ba8SPL set ID d87274cf-97b5-4965-9187-caec621e6177UNII SK47B8698TUPC 0893198002372
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

N461594000300 followed by a unit qualifier and the quantity

Package 61594-0003-00. 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 muscle cramps releases muscle tightness reduces muscle soreness

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61594-003

What is NDC 61594-003?
61594-003 is the product NDC for Theraworx Relief Muscle Cramp and Spasm Relief, Magnesium sulfate heptahydrate 6 [hp_X]/210mL 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 Muscle Cramp and Spasm Relief (Magnesium sulfate heptahydrate).
What is the active ingredient?
Magnesium sulfate heptahydrate.
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 Muscle Cramp and Spasm Relief?
1 other product NDC are listed under this name. See all Theraworx Relief Muscle Cramp and Spasm Relief NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Theraworx Relief Muscle Cramp and Spasm Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Theraworx Relief Muscle Cramp and Spasm Reliefmagnesium sulfate heptahydrateMagnesium sulfate heptahydrate 6 [hp_X]/210mLSpray, MeteredTopicalAVADIM HOLDINGS, INC61594-00461594-0004-00

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