Prescription drug · NDA
Tymlos (abaloparatide) NDC 70539-001
Abaloparatide 3.12 mg/1.56mL · Injection, Solution · Subcutaneous · Radius Health, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70539-001-02 | 70539000102 | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01)Marketed from May 1, 2017 | |
| 70539-001-98 | 70539000198 | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99)Marketed from May 1, 2017 · Sample package |
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)
- Tymlos
- Generic name (nonproprietary)
- abaloparatide
- Active ingredients
- Abaloparatide — 3.12 mg/1.56mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Radius Health, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208743
- Marketing start
- Listing expires
- Other FDA classes
- Parathyroid Hormone-Related Protein (Chemical structure)
- Identifiers
- Product ID 70539-001_f1834fb1-55c0-46ca-9da4-d03e867b3b8bSPL ID f1834fb1-55c0-46ca-9da4-d03e867b3b8bSPL set ID 712143d9-e21e-4013-bb3b-3426a21060a8RxCUI 1921075, 1921081UNII AVK0I6HY2U
- Pharmacologic class
- Parathyroid Hormone-Related Peptide 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470539000102followed by a unit qualifier and the quantityPackage 70539-0001-02. 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)
TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1.1 ) Treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1.2 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk …
Excerpt only. Read the full label for complete information.
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.