Home NDC 70539-001 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208743-001 TYMLOS ABALOPARATIDE 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208743-001 8748382 2027-10-03 U-2009 2017-05-25 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 N208743-001 RE49444 2031-04-28 U-2009 2023-03-14 N208743-001 RE49444 2031-04-28 U-3543 2023-03-14 N208743-001 10996208 2038-04-30 Drug product 2021-06-01 N208743-001 11782041 2038-04-30 U-2009 Drug product 2023-10-23 N208743-001 11782041 2038-04-30 U-3543 Drug product 2023-10-23 N208743-001 11977067 2038-04-30 Drug product 2024-05-16 N208743-001 11255842 2040-01-10 U-3322 2022-03-14 N208743-001 11680942 2040-01-10 U-3322 2023-07-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208743-001 TYMLOS 3.12MG/1.56ML (2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2017-04-28 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 9 · 327 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 8748382 2027-10-03 U-2009 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 RE49444 2031-04-28 U-2009 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 RE49444 2031-04-28 U-3543 2023-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 10996208 2038-04-30 Drug product 2021-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11782041 2038-04-30 U-2009 Drug product 2023-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11782041 2038-04-30 U-3543 Drug product 2023-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11977067 2038-04-30 Drug product 2024-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11255842 2040-01-10 U-3322 2022-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208743-001 11680942 2040-01-10 U-3322 2023-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 8748382 2027-10-03 U-2009 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 RE49444 2031-04-28 U-2009 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 RE49444 2031-04-28 U-3543 2023-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 10996208 2038-04-30 Drug product 2021-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11782041 2038-04-30 U-2009 Drug product 2023-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11782041 2038-04-30 U-3543 Drug product 2023-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11977067 2038-04-30 Drug product 2024-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11255842 2040-01-10 U-3322 2022-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208743-001 11680942 2040-01-10 U-3322 2023-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 8748382 2027-10-03 U-2009 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 RE49444 2031-04-28 U-2009 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 RE49444 2031-04-28 U-3543 2023-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 10996208 2038-04-30 Drug product 2021-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11782041 2038-04-30 U-2009 Drug product 2023-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11782041 2038-04-30 U-3543 Drug product 2023-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11977067 2038-04-30 Drug product 2024-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11255842 2040-01-10 U-3322 2022-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208743-001 11680942 2040-01-10 U-3322 2023-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 8748382 2027-10-03 U-3543 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 8748382 2027-10-03 U-2009 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 8148333 2027-11-08 Drug product 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208743-001 7803770 2031-04-28 U-2009 2017-05-25 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 65 observed states.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AVK0I6HY2U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1921075 Internal RxNorm lookup 1921081 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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