Home NDC 0002-8400 Forteo
Product NDC 0002-8400
11-digit product format 000028400
Labeler code 0002
Product ID 0002-8400_31aeb334-c6d1-4018-af85-17ef69850001
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriparatide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Eli Lilly and Company
Application NDA021318
Marketing category NDA
Marketing start 2002-11-26
Marketing end 2027-02-02
Substance TERIPARATIDE
Active strength 250 ug/mL
Pharmacologic classes Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]
NDC exclude flag No
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021318-001 FORTEO TERIPARATIDE 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 N021318-002 FORTEO TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021318-002 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.
Product history page 1 of 3 · 82 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 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021318-002 FORTEO 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021318-002 FORTEO 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021318-002 FORTEO 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021318-002 FORTEO 0.56MG/2.24ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) INJECTABLE / SUBCUTANEOUS 2002-11-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2008-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021318-001 FORTEO 0.75MG/3ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS 2002-11-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021318-002 FORTEO 0.6MG/2.4ML (0.25MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-06-25 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 101 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021318-001 6977077 2019-08-19 U-597 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-001 7163684 2019-08-19 U-790 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-001 7351414 2019-08-19 U-865 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-002 6977077 2019-08-19 U-994 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-002 6977077 2019-08-19 U-982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-002 7163684 2019-08-19 U-994 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-002 7163684 2019-08-19 U-983 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-002 7351414 2019-08-19 U-994 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-002 7351414 2019-08-19 U-984 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021318-001 7517334 2025-03-25 Drug product 2014-09-10 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021318-002 7517334 2025-03-25 Drug product 2014-09-10 8869cabd3fbd…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 N021318-001 M-302 2023-11-16 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N021318-002 M-302 2023-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021318-001 M-302 2023-11-16 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021318-002 M-302 2023-11-16 a72a2bbeb626…
Additional Listing Data#
Finished product Yes
Brand name base Forteo 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1435115 Internal RxNorm lookup 1435117 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 0002-8400-01 Forteo 2.24 mL in 1 SYRINGE INJECTION, SOLUTION 2.24 42 0002-8400-01 Forteo 1 in 1 CARTON INJECTION, SOLUTION 1 42
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Teriparatide ACTIVE INGREDIENT 10T9CSU89I FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23 Teriparatide ACTIVE MOIETY 10T9CSU89I FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23 acetic acid INACTIVE INGREDIENT Q40Q9N063P FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23 hydrochloric acid INACTIVE INGREDIENT QTT17582CB FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23 mannitol INACTIVE INGREDIENT 3OWL53L36A FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23 Metacresol INACTIVE INGREDIENT GGO4Y809LO FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23 sodium acetate anhydrous INACTIVE INGREDIENT NVG71ZZ7P0 FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23 water INACTIVE INGREDIENT 059QF0KO0R FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-8400 FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 40 Current NDC, Legacy NDC, 2 package rows 20241213_aae667c5-381f-4f92-93df-2ed6158d07b0.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 · 2 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 0002-8400-01 00002840001 1 SYRINGE in 1 CARTON (0002-8400-01) / 2.24 mL in 1 SYRINGE 1 syringe 2008-10-01 2027-02-02 No No Current