What is NDC 70954-301?

70954-301 is the product NDC for Mesalamine, Mesalamine 4 g/60mL suspension, 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 70954. 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 70954-301 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0301Add 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
70954-301-20	7095403012070954030120	7 BOTTLE in 1 CARTON (70954-301-20) / 60 mL in 1 BOTTLE (70954-301-10)Marketed from May 14, 2026

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: ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215269
Marketing start: May 14, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 70954-301_9411a710-a60c-4f4b-a28c-1f72d80eaf35SPL ID 9411a710-a60c-4f4b-a28c-1f72d80eaf35SPL set ID 485ed763-976e-4410-a401-7ff762a931b3RxCUI 238151UNII 4Q81I59GXCUPC 0370954301103
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

N470954030120 followed by a unit qualifier and the quantity

Package 70954-0301-20. 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 May 20, 2026.

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)

About NDC 70954-301

What is NDC 70954-301?: 70954-301 is the product NDC for Mesalamine, Mesalamine 4 g/60mL suspension, 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 70954. 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 4 g/60mL	SuspensionRectal	KLM Laboratories Private Limited	84725-002	84725-0002-0484725-0002-10
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 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
Mesalamine	Mesalamine .375 g/1	Capsule, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-371	50742-0371-12

All 59 Mesalamine NDCs