Home NDC 0093-1106 Teriparatide
Product NDC 0093-1106
11-digit product format 000931106
Labeler code 0093
Product ID 0093-1106_5e3977c0-a361-494b-ac07-0426dda5bd36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriparatide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA208569
Marketing category ANDA
Marketing start 2023-12-18
Substance TERIPARATIDE ACETATE
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 A208569-001 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 A208569-001 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 A208569-001 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 A208569-001 TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208569-001 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 A208569-001 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 A208569-001 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 A208569-001 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 A208569-001 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 A208569-001 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 A208569-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208569-001 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 A208569-001 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 A208569-001 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 A208569-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208569-001 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 A208569-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208569-001 TERIPARATIDE 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208569-001 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 A208569-001 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERIPARATIDE ACETATE 250 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9959P4V12N 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 0093-1106-16 Teriparatide 1 in 1 CARTON INJECTION, SOLUTION 1 3 0093-1106-16 Teriparatide 2.24 mL in 1 SYRINGE INJECTION, SOLUTION 2.24 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-1106 TERIPARATIDE INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.] 3 Current NDC, 2 package rows 20250313_d371f0f7-d492-4481-b360-051456d56d65.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 0093-1106-16 00093110616 1 SYRINGE in 1 CARTON (0093-1106-16) / 2.24 mL in 1 SYRINGE 1 syringe 2023-12-18 No No Current