NDC codes

FDA NDC Directory
Product NDC (as listed)69918-560Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69918-0560Add 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
69918-560-30699180560306991805603030 SUPPOSITORY in 1 BOX (69918-560-30)Marketed from Jun 24, 2019

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 Rectal
Generic name (nonproprietary)
mesalamine
Active ingredients
Mesalamine — 1000 mg/1
Dosage form
Suppository
Route
Rectal
Labeler
Amring Pharmaceuticals Inc.NDC labeler code 69918
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208362
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 69918-560_795356f9-9817-4b51-8de6-4504a2a48abdSPL ID 795356f9-9817-4b51-8de6-4504a2a48abdSPL set ID 87de237c-febb-42ca-b2a4-b444396f8640RxCUI 248420UNII 4Q81I59GXC
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

N469918056030 followed by a unit qualifier and the quantity

Package 69918-0560-30. 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)

1. INDICATIONS AND USAGE Mesalamine Rectal Suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. Mesalamine Rectal 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 69918-560

What is NDC 69918-560?
69918-560 is the product NDC for Mesalamine Rectal (mesalamine), Mesalamine 1000 mg/1 suppository, listed with the FDA by Amring Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mesalamine Rectal (Mesalamine).
What is the active ingredient?
Mesalamine.
Who is the labeler?
Amring Pharmaceuticals Inc., NDC labeler code 69918. 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 Rectal?
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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