What is NDC 62559-420?

62559-420 is the product NDC for Mesalamine, Mesalamine 4 g/60mL enema, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 62559. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mesalamine NDC 62559-420 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)62559-420Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62559-0420Add 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
62559-420-07	62559042007	7 BOTTLE in 1 BOX (62559-420-07) / 60 mL in 1 BOTTLE (62559-420-11)Marketed from May 13, 2016

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: Enema
Route: Rectal
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 019618
Marketing start: May 13, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 62559-420_def117ab-832b-4d92-b005-cf2f53d52899SPL ID def117ab-832b-4d92-b005-cf2f53d52899SPL set ID 3cf751f2-a0c9-45d7-8acb-2bc61db0e4acRxCUI 238151UNII 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

N462559042007 followed by a unit qualifier and the quantity

Package 62559-0420-07. 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 Feb 14, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Mesalamine Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-420

What is NDC 62559-420?: 62559-420 is the product NDC for Mesalamine, Mesalamine 4 g/60mL enema, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, 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?: ANI Pharmaceuticals, Inc., NDC labeler code 62559. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Mesalamine	Mesalamine 250 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2791	00781-2791-64
Mesalamine	Mesalamine 500 mg/1	Capsule, Extended releaseOral	Sandoz Inc	0781-2793	00781-2793-72
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Nuvaila Limited	84612-175	84612-0175-13
Mesalamine	Mesalamine 4 g/60mL	SuspensionRectal	ANI Pharmaceuticals, Inc.	70954-301	70954-0301-20
Mesalamine	Mesalamine 4 g/60mL	SuspensionRectal	KLM Laboratories Private Limited	84725-002	84725-0002-03
Mesalamine	Mesalamine 375 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-489	31722-0489-12
Mesalamine	Mesalamine 1000 mg/1	SuppositoryRectal	Rising Pharma Holdings, Inc.	16571-246	16571-0246-0316571-0246-72
Mesalamine	Mesalamine 800 mg/1	Tablet, Delayed releaseOral	Amneal Pharmaceuticals LLC	65162-360	65162-0360-18
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	NorthStar RxLLC	72603-304	72603-0304-01
Mesalamine	Mesalamine 800 mg/1	Tablet, Delayed releaseOral	AvKARE	42291-489	42291-0489-18

All 59 Mesalamine NDCs

Other NDCs under NDA 019618

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

FDA NDC Directory listings under NDA 019618
Product	Strength	Form · route	Labeler	Product NDC
Rowasamesalamine	Mesalamine 4 g/60mL	SuspensionRectal	Viatris Specialty LLC	0037-0066