NDC codes

FDA NDC Directory
Product NDC (as listed)62135-714Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0714Add 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
62135-714-126213507141262135071412120 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-714-12)Marketed from Jul 21, 2023
62135-714-60621350714606213507146060 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-714-60)Marketed from Jul 21, 2023

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 — 1.2 g/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217337
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 62135-714_462a53ff-353f-3cdf-e063-6394a90af853SPL ID 462a53ff-353f-3cdf-e063-6394a90af853SPL set ID 9703f92d-1d15-4376-8b2b-51502c266012RxCUI 686429UNII 4Q81I59GXCUPC 0362135714123, 0362135714604
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

N462135071412 followed by a unit qualifier and the quantity

Package 62135-0714-12. 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 .

Indications (excerpt from the label)

Mesalamine delayed-release tablets are indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. Pediatric use information is approved for Takeda Pharmaceuticals U.S.A., Inc.’s LIALDA (mesalamine) delayed-release tablets. However, due to Takeda Pharmaceuticals U.S.A., Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Mesalamine delayed-release tablets are an aminosalicylate indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-714

What is NDC 62135-714?
62135-714 is the product NDC for Mesalamine, Mesalamine 1.2 g/1 tablet, delayed release, listed with the FDA by Chartwell RX, LLC. 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?
Chartwell RX, LLC, NDC labeler code 62135. 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 217337

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

FDA NDC Directory listings under ANDA 217337
ProductStrengthForm · routeLabelerProduct NDC
MesalamineMesalamine 1.2 g/1Tablet, Delayed releaseOralLannett Company Inc.0527-3012
MesalamineMesalamine 1.2 g/1Tablet, Delayed releaseOralBryant Ranch Prepack72162-2213

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