NDC codes

FDA NDC Directory
Product NDC (as listed)82009-199Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0199Add 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
82009-199-30820090199308200901993030 TABLET, FILM COATED in 1 BOTTLE (82009-199-30)Marketed from Oct 15, 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)
Eltrombopag
Generic name (nonproprietary)
eltrombopag
Active ingredients
Eltrombopag olamine — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Quallent Pharmaceuticals Health LLCNDC labeler code 82009
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206788
Marketing start
Listing expires
Other FDA classes
Breast Cancer Resistance Protein Inhibitors (Mechanism)Increased Megakaryocyte Maturation (Physiologic effect)Increased Platelet Production (Physiologic effect)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Thrombopoietin Receptor Agonists (Mechanism)UGT1A1 Inhibitors (Mechanism)UGT1A3 Inhibitors (Mechanism)UGT1A4 Inhibitors (Mechanism)UGT1A6 Inhibitors (Mechanism)UGT1A9 Inhibitors (Mechanism)UGT2B15 Inhibitors (Mechanism)UGT2B7 Inhibitors (Mechanism)
Identifiers
Product ID 82009-199_5577641b-9b90-58c0-e063-6294a90adeebSPL ID 5577641b-9b90-58c0-e063-6294a90adeebSPL set ID 9760d6fb-9e64-40c0-9f66-d9b92b89e762RxCUI 825421, 825427, 884617, 1245001UNII 4U07F515LGUPC 0382009201306, 0382009200309, 0382009199306
Pharmacologic class
Thrombopoietin Receptor Agonist

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

N482009019930 followed by a unit qualifier and the quantity

Package 82009-0199-30. 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)

Eltrombopag tablet is a thrombopoietin receptor agonist indicated: • for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1) • for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82009-199

What is NDC 82009-199?
82009-199 is the product NDC for Eltrombopag, Eltrombopag olamine 25 mg/1 tablet, film coated, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Eltrombopag.
What is the active ingredient?
Eltrombopag olamine.
Who is the labeler?
Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eltrombopag?
37 other product NDCs are listed under this name. See all Eltrombopag 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 Eltrombopag NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EltrombopagEltrombopag olamine 50 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-260000480-2600-56
EltrombopagEltrombopag olamine 12.5 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-401500480-4015-56
EltrombopagEltrombopag olamine 75 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-403100480-4031-56
EltrombopagEltrombopag olamine 25 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-421000480-4210-56
EltrombopagEltrombopag olamine 12.5 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-18370377-0183-11
Eltrombopageltrombopag olamineEltrombopag olamine 25 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-18470377-0184-1170377-0184-12
Eltrombopageltrombopag olamineEltrombopag olamine 50 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-18570377-0185-1170377-0185-1270377-0185-13
Eltrombopageltrombopag olamineEltrombopag olamine 75 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-18670377-0186-1170377-0186-12
Eltrombopageltrombopag olamineEltrombopag olamine 12.5 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-096200054-0962-13
Eltrombopageltrombopag olamineEltrombopag olamine 25 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-096300054-0963-13

All 38 Eltrombopag NDCs

Other NDCs under ANDA 206788

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

FDA NDC Directory listings under ANDA 206788
ProductStrengthForm · routeLabelerProduct NDC
EltrombopagEltrombopag olamine 12.5 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-841
EltrombopagEltrombopag olamine 25 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-842
EltrombopagEltrombopag olamine 50 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-843
EltrombopagEltrombopag olamine 75 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-844
EltrombopagEltrombopag olamine 12.5 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-299
EltrombopagEltrombopag olamine 25 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-300
EltrombopagEltrombopag olamine 50 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-301
EltrombopagEltrombopag olamine 75 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-302

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