NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1110Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1110Add 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
70771-1110-4707711110047077111100410 BLISTER PACK in 1 CARTON (70771-1110-4) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70771-1110-2)Marketed from Aug 2, 2018
70771-1110-87077111100870771111008180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1110-8)Marketed from Aug 2, 2018

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 — 800 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203286
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 70771-1110_b22ba9c9-d644-4ea2-a21d-0f8dee960c43SPL ID b22ba9c9-d644-4ea2-a21d-0f8dee960c43SPL set ID 52d96501-47f3-45d8-a181-98763b9f8965RxCUI 833234UNII 4Q81I59GXCUPC 0368382435286
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470771111004 followed by a unit qualifier and the quantity

Package 70771-1110-04. 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 70771-1110

What is NDC 70771-1110?
70771-1110 is the product NDC for mesalamine, Mesalamine 800 mg/1 tablet, delayed release, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, 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 203286

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

FDA NDC Directory listings under ANDA 203286
ProductStrengthForm · routeLabelerProduct NDC
MesalamineMesalamine 800 mg/1Tablet, Delayed releaseOralAmerican Health Packaging60687-408
mesalamineMesalamine 800 mg/1Tablet, Delayed releaseOralZydus Pharmaceuticals USA Inc.68382-435

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