Home NDC 60505-6188 Teriparatide
Product NDC 60505-6188
11-digit product format 605056188
Labeler code 60505
Product ID 60505-6188_c8cf0fe9-9287-b220-3049-a45dba576ee1
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 2026-09-14 22:38:34 2026-08 A211097-001 TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211097-001 TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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) / 2.24 mL in 1 SYRINGE 1 syringe 2023-11-17 No No Current