What is NDC 0037-0066?

0037-0066 is the product NDC for Rowasa (mesalamine), Mesalamine 4 g/60mL suspension, listed with the FDA by Viatris Specialty LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Viatris Specialty LLC, NDC labeler code 0037. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Rowasa?

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.

Rowasa NDC 0037-0066 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0037-0066Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00037-0066Add 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
0037-0066-03	0003700660300037006603	28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)Marketed from Mar 24, 2016
0037-0066-05	0003700660500037006605	7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)Marketed from Mar 24, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Rowasa
Generic name (nonproprietary): mesalamine
Active ingredients: Mesalamine — 4 g/60mL
Dosage form: Suspension
Route: Rectal
Labeler: Viatris Specialty LLCNDC labeler code 0037
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019618
Marketing start: Mar 24, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 0037-0066_8c9b1d5d-7391-4bf0-b0d5-079c5c45526fSPL ID 8c9b1d5d-7391-4bf0-b0d5-079c5c45526fSPL set ID e505ab99-1943-4216-a178-4d5dbe64e3b2RxCUI 206798, 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

N400037006603 followed by a unit qualifier and the quantity

Package 00037-0066-03. 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 Aug 3, 2026.

Indications (excerpt from the label)

ROWASA is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ROWASA 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)

About NDC 0037-0066

What is NDC 0037-0066?: 0037-0066 is the product NDC for Rowasa (mesalamine), Mesalamine 4 g/60mL suspension, listed with the FDA by Viatris Specialty LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rowasa (Mesalamine).
What is the active ingredient?: Mesalamine.
Who is the labeler?: Viatris Specialty LLC, NDC labeler code 0037. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rowasa?: 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.

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
Mesalamine	Mesalamine 4 g/60mL	EnemaRectal	ANI Pharmaceuticals, Inc.	62559-420

Rowasa (Mesalamine) NDC 0037-0066