Prescription drug · NDA
Doptelet (Avatrombopag maleate) NDC 71369-020
Avatrombopag maleate 20 mg/1 · Tablet, Film coated · Oral · AkaRx, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71369-020-10 | 71369002010 | 1 BLISTER PACK in 1 CARTON (71369-020-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11)Marketed from May 23, 2018 | |
| 71369-020-15 | 71369002015 | 1 BLISTER PACK in 1 CARTON (71369-020-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16)Marketed from May 23, 2018 | |
| 71369-020-30 | 71369002030 | 2 BLISTER PACK in 1 CARTON (71369-020-30) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16)Marketed from Jun 26, 2019 |
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)
- Doptelet
- Generic name (nonproprietary)
- avatrombopag maleate
- Active ingredients
- Avatrombopag maleate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AkaRx, Inc.NDC labeler code 71369
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210238
- Marketing start
- Listing expires
- Identifiers
- Product ID 71369-020_4d4d84be-34cd-4027-b69a-2f16ec5049edSPL ID 4d4d84be-34cd-4027-b69a-2f16ec5049edSPL set ID e2d5960d-6c18-46cc-86bd-089222b09852RxCUI 2045951, 2045952, 2045958, 2045959, 2045960, 2045961, 2721188, 2721192UNII GDW7M2P1IS
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
N471369002010followed by a unit qualifier and the quantityPackage 71369-0020-10. 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)
DOPTELET is a thrombopoietin receptor agonist indicated for the treatment of: Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. ( 1.1 ) Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. ( 1.2 ) Thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment ( 1.3 ) 1.1 Treatment of Thrombocytopenia in Patients with Chronic Liver Disease (CLD) DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who ar…
Excerpt only. Read the full label for complete information.
About NDC 71369-020
- What is NDC 71369-020?
- 71369-020 is the product NDC for Doptelet (avatrombopag maleate), Avatrombopag maleate 20 mg/1 tablet, film coated, listed with the FDA by AkaRx, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doptelet (Avatrombopag maleate).
- What is the active ingredient?
- Avatrombopag maleate.
- Who is the labeler?
- AkaRx, Inc., NDC labeler code 71369. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doptelet?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.