Home NDC 66993-495 Teriparatide
Product NDC 66993-495
11-digit product format 669930495
Labeler code 66993
Product ID 66993-495_0bc59709-3046-4364-b275-14464c1e9f8f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Teriparatide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Prasco Laboratories
Application NDA021318
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-11-17
Marketing end 2027-03-04
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 Teriparatide 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 66993-495-28 Teriparatide 1 in 1 CARTON INJECTION, SOLUTION 1 8 66993-495-28 Teriparatide 2.24 mL in 1 SYRINGE INJECTION, SOLUTION 2.24 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-495 TERIPARATIDE INJECTION, SOLUTION [PRASCO LABORATORIES] 7 Current NDC, 2 package rows 20241215_ab322675-4769-45b0-b146-14fbaa3135d0.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 66993-495-28 66993049528 1 SYRINGE in 1 CARTON (66993-495-28) / 2.24 mL in 1 SYRINGE 1 syringe 2023-11-17 2027-03-04 No No Historical