NDC codes

FDA NDC Directory
Product NDC (as listed)76282-698Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76282-0698Add 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
76282-698-48762820698487628206984828 CAPSULE in 1 BOTTLE, PLASTIC (76282-698-48)Marketed from Sep 6, 2022

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)
lenalidomide
Generic name (nonproprietary)
lenalidomide
Active ingredients
Lenalidomide — 10 mg/1
Dosage form
Capsule
Route
Oral
Labeler
EXELAN PHARMACEUTICALS INC.NDC labeler code 76282
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210435
Marketing start
Listing expires
Identifiers
Product ID 76282-698_e6e7ab13-5475-4755-8e1a-f643425297b7SPL ID e6e7ab13-5475-4755-8e1a-f643425297b7SPL set ID 682e8a86-9f49-45db-a2ea-403ee1dc62d2RxCUI 602910, 602912, 643712, 643720, 1428947UNII F0P408N6V4
Pharmacologic class
Thalidomide Analog

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

N476282069848 followed by a unit qualifier and the quantity

Package 76282-0698-48. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3 ). Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). Previously …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76282-698

What is NDC 76282-698?
76282-698 is the product NDC for lenalidomide, Lenalidomide 10 mg/1 capsule, listed with the FDA by EXELAN PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
lenalidomide.
What is the active ingredient?
Lenalidomide.
Who is the labeler?
EXELAN PHARMACEUTICALS INC., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for lenalidomide?
107 other product NDCs are listed under this name. See all lenalidomide 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 lenalidomide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LenalidomideLenalidomide 2.5 mg/1CapsuleOralAccord Healthcare Inc.16729-69216729-0692-09
LenalidomideLenalidomide 25 mg/1CapsuleOralAccord Healthcare Inc.16729-69716729-0697-06
LenalidomideLenalidomide 15 mg/1CapsuleOralAccord Healthcare Inc.16729-69516729-0695-06
LenalidomideLenalidomide 5 mg/1CapsuleOralAccord Healthcare Inc.16729-69316729-0693-09
LenalidomideLenalidomide 20 mg/1CapsuleOralAccord Healthcare Inc.16729-69616729-0696-06
LenalidomideLenalidomide 10 mg/1CapsuleOralAccord Healthcare Inc.16729-69416729-0694-09
LenalidomideLenalidomide 2.5 mg/1CapsuleOralPadagis US LLC0574-140200574-1402-28
LenalidomideLenalidomide 5 mg/1CapsuleOralPadagis US LLC0574-140500574-1405-28
LenalidomideLenalidomide 10 mg/1CapsuleOralPadagis US LLC0574-141000574-1410-28
LenalidomideLenalidomide 15 mg/1CapsuleOralPadagis US LLC0574-141500574-1415-21

All 108 lenalidomide NDCs

Other NDCs under ANDA 210435

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

FDA NDC Directory listings under ANDA 210435
ProductStrengthForm · routeLabelerProduct NDC
lenalidomideLenalidomide 5 mg/1CapsuleOralCipla USA Inc.69097-381
lenalidomideLenalidomide 10 mg/1CapsuleOralCipla USA Inc.69097-382
lenalidomideLenalidomide 15 mg/1CapsuleOralCipla USA Inc.69097-383
lenalidomideLenalidomide 20 mg/1CapsuleOralCipla USA Inc.69097-384
lenalidomideLenalidomide 25 mg/1CapsuleOralCipla USA Inc.69097-385
lenalidomideLenalidomide 5 mg/1CapsuleOralEXELAN PHARMACEUTICALS INC.76282-697
lenalidomideLenalidomide 15 mg/1CapsuleOralEXELAN PHARMACEUTICALS INC.76282-699
lenalidomideLenalidomide 20 mg/1CapsuleOralEXELAN PHARMACEUTICALS INC.76282-700
lenalidomideLenalidomide 25 mg/1CapsuleOralEXELAN PHARMACEUTICALS INC.76282-701

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