Home NDC 60505-6188 Teriparatide
Product NDC 60505-6188
11-digit product format 605056188
Labeler code 60505
Product ID 60505-6188_8f15c891-ec65-6632-c161-e7bddfc3b3f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriparatide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Apotex Corp.
Application ANDA211097
Marketing category ANDA
Marketing start 2023-11-16
Substance TERIPARATIDE
Active strength 250 ug/mL
Pharmacologic classes Parathyroid Hormone Analog [EPC], Parathyroid Hormone [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 A211097-001 TERIPARATIDE TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211097-001 AP
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.
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 A211097-001 TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211097-001 TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211097-001 TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211097-001 TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211097-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211097-001 TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Teriparatide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERIPARATIDE 250 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 10T9CSU89I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1435115 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 60505-6188-0 Teriparatide 1 in 1 CARTON INJECTION, SOLUTION 1 8 60505-6188-0 Teriparatide 2.4 mL in 1 SYRINGE INJECTION, SOLUTION 2.4 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6188 TERIPARATIDE INJECTION, SOLUTION [APOTEX CORP.] 7 Current NDC, 2 package rows 20250511_d77d40db-7f38-88eb-fd5d-4282f0642028.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 Sample Exclude flag Status 60505-6188-0 60505618800 1 SYRINGE in 1 CARTON (60505-6188-0) / 2.4 mL in 1 SYRINGE 1 syringe 2023-11-17 No No Current