FDA.reportPublic FDA data

NDC 70539-001-01 - Tymlos

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70539-001
Requested NDC
70539-001-01
Package NDCs from labels
70539-001-01, 70539-001-02, 70539-001-99, 70539-001-98
Manufacturer
Radius Health, Inc. | PolyPeptide SA | Vetter Pharma-Fertigung GmbH & Co. KG | Novocol Pharmaceuticals of Canada, Inc
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TymlosRadius Health, Inc. | PolyPeptide SA | Vetter Pharma-Fertigung GmbH & Co. KG | Novocol Pharmaceuticals of Canada, Inc2026-08-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70539-001-01Tymlos1.56 mL in 1 CARTRIDGEINJECTION, SOLUTION1.5618
70539-001-02Tymlos1 in 1 BOX, UNIT-DOSEINJECTION, SOLUTION118
70539-001-98Tymlos1 in 1 BOX, UNIT-DOSEINJECTION, SOLUTION118
70539-001-99Tymlos1.56 mL in 1 CARTRIDGEINJECTION, SOLUTION1.5618

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70539-001TYMLOS (ABALOPARATIDE) INJECTION, SOLUTION [RADIUS HEALTH, INC.]18Current NDC, Legacy NDC, 4 package rows20250411_712143d9-e21e-4013-bb3b-3426a21060a8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70539-001-01ML - Milliliter70539-001a36446df-efcd-4aee-bb5f-aae55792c67612017-06-15
70539-001-02ML - Milliliter70539-00143f82a38-f62c-4249-bbc7-47eb49443f2512017-06-15

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 9 of 18 · 359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a2bc45d-e0c8-3af2-e053-2a95a90af0f12025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67169d-6b15-3406-e053-2995a90a60e42025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a673225-27be-040a-e053-2a95a90a0a982025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66b61d-82bd-2bbb-e053-2995a90a0b582025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a677063-09d2-8052-e053-2a95a90affae2025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a678fac-289c-0f5c-e053-2995a90a0f432025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66da0b-ee7b-2b69-e053-2995a90ae9512025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a667d80-d05c-2d18-e053-2995a90a29182025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66e2a9-a661-e847-e053-2a95a90aa3042025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67a0bb-6943-2f5f-e053-2a95a90aac6e2025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a6711a9-e0a4-9083-e053-2a95a90ad4a42025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67bb27-cb44-4a1d-e053-2a95a90a0ee22025-01-09Exact identifier
unii: Q40Q9N063P
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: Q40Q9N063P

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.