NDC codes

FDA NDC Directory
Product NDC (as listed)31722-005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0005Add 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
31722-005-3031722000530317220005305 PACKAGE in 1 CARTON (31722-005-30) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)Marketed from Mar 19, 2020
31722-005-3131722000531317220005317 PACKAGE in 1 CARTON (31722-005-31) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)Marketed from Mar 19, 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

Brand name (proprietary)
Mesalamine
Generic name (nonproprietary)
mesalamine
Active ingredients
Mesalamine — 1000 mg/1
Dosage form
Suppository
Route
Rectal
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213377
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 31722-005_1248c2d3-b241-5551-e063-6294a90a2f4eSPL ID 1248c2d3-b241-5551-e063-6294a90a2f4eSPL set ID efa9d039-ae1f-4cd6-98f2-e87a901dfaebRxCUI 248420UNII 4Q81I59GXCUPC 0331722005302, 0331722005319
Pharmacologic class
Aminosalicylate

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N431722000530 followed by a unit qualifier and the quantity

Package 31722-0005-30. 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)

Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. Mesalamine suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-005

What is NDC 31722-005?
31722-005 is the product NDC for Mesalamine, Mesalamine 1000 mg/1 suppository, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mesalamine.
What is the active ingredient?
Mesalamine.
Who is the labeler?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mesalamine?
58 other product NDCs are listed under this name. See all Mesalamine 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 Mesalamine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MesalamineMesalamine 4 g/60mLSuspensionRectalKLM Laboratories Private Limited84725-00284725-0002-0484725-0002-10
MesalamineMesalamine 250 mg/1Capsule, Extended releaseOralSandoz Inc0781-279100781-2791-64
MesalamineMesalamine 500 mg/1Capsule, Extended releaseOralSandoz Inc0781-279300781-2793-72
MesalamineMesalamine 1.2 g/1Tablet, Delayed releaseOralNuvaila Limited84612-17584612-0175-13
MesalamineMesalamine 4 g/60mLSuspensionRectalANI Pharmaceuticals, Inc.70954-30170954-0301-20
MesalamineMesalamine 375 mg/1Capsule, Extended releaseOralCamber Pharmaceuticals, Inc.31722-48931722-0489-12
MesalamineMesalamine 1000 mg/1SuppositoryRectalRising Pharma Holdings, Inc.16571-24616571-0246-0316571-0246-72
MesalamineMesalamine 800 mg/1Tablet, Delayed releaseOralAmneal Pharmaceuticals LLC65162-36065162-0360-18
MesalamineMesalamine 1.2 g/1Tablet, Delayed releaseOralNorthStar RxLLC72603-30472603-0304-01
MesalamineMesalamine 800 mg/1Tablet, Delayed releaseOralAvKARE42291-48942291-0489-18

All 59 Mesalamine NDCs

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