NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1513Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1513Add 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
70771-1513-770771151307707711513075 BLISTER PACK in 1 POUCH (70771-1513-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70771-1513-6)Marketed from Feb 14, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1000 mg/1
Dosage form
Suppository
Route
Rectal
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208953
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 70771-1513_923f1e77-becd-45e6-a9e8-12cd5942c828SPL ID 923f1e77-becd-45e6-a9e8-12cd5942c828SPL set ID aa63b4bb-2de7-40aa-b26b-1b00b0183eacRxCUI 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

N470771151307 followed by a unit qualifier and the quantity

Package 70771-1513-07. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1513

What is NDC 70771-1513?
70771-1513 is the product NDC for Mesalamine, Mesalamine 1000 mg/1 suppository, listed with the FDA by Zydus Lifesciences Limited. 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MesalamineMesalamine 4 g/60mLSuspensionRectalKLM Laboratories Private Limited84725-00284725-0002-0484725-0002-10
MesalamineMesalamine 250 mg/1Capsule, Extended releaseOralSandoz Inc0781-279100781-2791-64
MesalamineMesalamine 500 mg/1Capsule, Extended releaseOralSandoz Inc0781-279300781-2793-72
MesalamineMesalamine 1.2 g/1Tablet, Delayed releaseOralNuvaila Limited84612-17584612-0175-13
MesalamineMesalamine 4 g/60mLSuspensionRectalANI Pharmaceuticals, Inc.70954-30170954-0301-20
MesalamineMesalamine 375 mg/1Capsule, Extended releaseOralCamber Pharmaceuticals, Inc.31722-48931722-0489-12
MesalamineMesalamine 1000 mg/1SuppositoryRectalRising Pharma Holdings, Inc.16571-24616571-0246-0316571-0246-72
MesalamineMesalamine 800 mg/1Tablet, Delayed releaseOralAmneal Pharmaceuticals LLC65162-36065162-0360-18
MesalamineMesalamine 1.2 g/1Tablet, Delayed releaseOralNorthStar RxLLC72603-30472603-0304-01
MesalamineMesalamine 800 mg/1Tablet, Delayed releaseOralAvKARE42291-48942291-0489-18

All 59 Mesalamine NDCs

Other NDCs under ANDA 208953

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

FDA NDC Directory listings under ANDA 208953
ProductStrengthForm · routeLabelerProduct NDC
MesalamineMesalamine 1000 mg/1SuppositoryRectalNorthstar Rx LLC.16714-245
MesalamineMesalamine 1000 mg/1SuppositoryRectalZydus Pharmaceuticals USA Inc.70710-1302

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