NDC codes

FDA NDC Directory
Product NDC (as listed)48783-112Labeler and product segments. Claims need a package NDC.
Product NDC at billing width48783-0112Add 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
48783-112-084878301120814 g in 1 VIAL, SINGLE-DOSE (48783-112-08)Marketed from Jun 10, 2014

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)
Monsels Solution
Generic name (nonproprietary)
ferric subsulfate
Active ingredients
Ferric subsulfate — 210 mg/g
Dosage form
Paste
Route
Topical
Labeler
Premier Dental Products CompanyNDC labeler code 48783
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
Identifiers
Product ID 48783-112_4847c0c4-f60a-2f71-e063-6294a90a5830SPL ID 4847c0c4-f60a-2f71-e063-6294a90a5830SPL set ID 7a9923af-b8ed-4dc5-b6ae-2f42f83eb3dbUNII 3QJ8WS6V8H
Pharmacologic class
Parenteral Iron Replacement; 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

N448783011208 followed by a unit qualifier and the quantity

Package 48783-0112-08. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 48783-112

What is NDC 48783-112?
48783-112 is the product NDC for Monsels Solution (ferric subsulfate), Ferric subsulfate 210 mg/g paste, listed with the FDA by Premier Dental Products Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Monsels Solution (Ferric Subsulfate).
What is the active ingredient?
Ferric subsulfate.
Who is the labeler?
Premier Dental Products Company, NDC labeler code 48783. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Monsels Solution?
1 other product NDC are listed under this name. See all Monsels Solution 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 Monsels Solution NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Monsels Solutionferric subsulfateFerric subsulfate 210 mg/gPasteTopicalPremier Dental Products Company48783-11348783-0113-08

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