Tymlos
- Product NDC
- 70539-001
- 11-digit product format
- 705390001
- Labeler code
- 70539
- Product ID
- 70539-001_72b77fcf-921b-426c-bb17-e1ccf8dc0f6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abaloparatide
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Radius Health, Inc.
- Application
- NDA208743
- Marketing category
- NDA
- Marketing start
- 2017-05-01
- Substance
- ABALOPARATIDE
- Active strength
- 3.12 mg/1.56mL
- Pharmacologic classes
- Parathyroid Hormone-Related Peptide Analog [EPC], Parathyroid Hormone-Related Protein [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tymlos
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ABALOPARATIDE | 3.12 mg/1.56mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AVK0I6HY2U |
| Rxcui | 1921075, 1921081 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70539-001-01 | Tymlos | 1.56 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.56 | | 18 |
| 70539-001-02 | Tymlos | 1 in 1 BOX, UNIT-DOSE | INJECTION, SOLUTION | 1 | | 18 |
| 70539-001-98 | Tymlos | 1 in 1 BOX, UNIT-DOSE | INJECTION, SOLUTION | 1 | | 18 |
| 70539-001-99 | Tymlos | 1.56 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.56 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70539-001 | TYMLOS (ABALOPARATIDE) INJECTION, SOLUTION [RADIUS HEALTH, INC.] | 18 | Current NDC, Legacy NDC, 4 package rows | 20250411_712143d9-e21e-4013-bb3b-3426a21060a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70539-001-01 | 70539000101 | 1.56 mL in 1 CARTRIDGE | 1.56 ml | | | | | Historical |
| 70539-001-02 | 70539000102 | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01) | 1 cartridge | 2017-05-01 | 0000-00-00 | No | No | Current |
| 70539-001-98 | 70539000198 | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99) | 1 cartridge | 2017-05-01 | 0000-00-00 | Yes | No | Current |
| 70539-001-99 | 70539000199 | 1.56 mL in 1 CARTRIDGE | 1.56 ml | | | | | Historical |