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NDC 70539-0001-02 Tymlos 3.12 mg/1.56mL Details
Tymlos 3.12 mg/1.56mL
Tymlos is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Radius Health, Inc.. The primary component is ABALOPARATIDE.
MedlinePlus Drug Summary
Abaloparatide injection is used to treat osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change in life,' end of menstrual periods), who are at high risk of fractures (broken bones) or who could not be treated successfully with other medications. Abaloparatide injection contains a synthetic form of a natural human hormone called parathyroid hormone (PTH). It works by causing the body to build new bone and by increasing bone strength and density (thickness).
Related Packages: 70539-0001-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Abaloparatide Injection
Product Information
| NDC | 70539-0001 |
|---|---|
| Product ID | 70539-001_5c342488-a83e-4581-b45c-9261285c39d8 |
| Associated GPIs | 3004400500D230 |
| GCN Sequence Number | 077351 |
| GCN Sequence Number Description | abaloparatide PEN INJCTR 80MCG/DOSE SUBCUT |
| HIC3 | P4F |
| HIC3 Description | BONE FORMATION STIMULATING AGTS - PTH REL PEPTIDES |
| GCN | 43334 |
| HICL Sequence Number | 044231 |
| HICL Sequence Number Description | ABALOPARATIDE |
| Brand/Generic | Brand |
| Proprietary Name | Tymlos |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | abaloparatide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 3.12 |
| Active Ingredient Units | mg/1.56mL |
| Substance Name | ABALOPARATIDE |
| Labeler Name | Radius Health, Inc. |
| Pharmaceutical Class | Parathyroid Hormone-Related Peptide Analog [EPC], Parathyroid Hormone-Related Protein [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208743 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70539-0001-02 (70539000102)
| NDC Package Code | 70539-001-02 |
|---|---|
| Billing NDC | 70539000102 |
| Package | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01) |
| Marketing Start Date | 2017-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1646.36 |
| Pricing Unit | ML |
| Effective Date | 2024-01-01 |
| NDC Description | TYMLOS 80 MCG DOSE PEN INJECTR |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
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