Mesalamine NDC 21922-045

NDC codes

FDA NDC Directory

Product NDC (as listed)21922-045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width21922-0045Add 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 NDC	11-digit (billing)	Package	Copy
21922-045-47	21922004547	7 BOTTLE, DISPENSING in 1 CARTON (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)Marketed from Jun 1, 2023
21922-045-49	21922004549	28 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)Marketed from Jun 1, 2023

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 — 4 g/60mL
Dosage form: Suspension
Route: Rectal
Labeler: Encube Ethicals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216941
Marketing start: Jun 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 21922-045_6ffc01fa-3cf5-4e6c-9760-7ff9873c82dfSPL ID 6ffc01fa-3cf5-4e6c-9760-7ff9873c82dfSPL set ID d6b68275-b2a4-4965-9862-cf14acf8c599RxCUI 238151UNII 4Q81I59GXCUPC 0321922045017
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

N421922004547 followed by a unit qualifier and the quantity

Package 21922-0045-47. 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 Oct 7, 2025.

Indications (excerpt from the label)

Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. Mesalamine rectal suspension enema is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216941

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216941
Product	Strength	Form · route	Labeler	Product NDC
Mesalamine	Mesalamine 4 g/60mL	SuspensionRectal	Bryant Ranch Prepack	72162-2302