Home NDC 42023-205 Calcitonin Salmon
Product NDC 42023-205
11-digit product format 420230205
Labeler code 42023
Product ID 42023-205_2b10f1b3-c5aa-4155-a17c-ad71119eb3ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitonin Salmon
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Par Health USA, LLC
Application ANDA209358
Marketing category ANDA
Marketing start 2021-11-10
Substance CALCITONIN SALMON
Active strength 200 [iU]/mL
Pharmacologic classes Calcitonin [CS], Calcitonin [EPC]
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 42 .
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 A209358-001 CALCITONIN-SALMON CALCITONIN SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209358-001 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 2026-08-18 06:07:40 2026-07 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209358-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2021-11-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Calcitonin Salmon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCITONIN SALMON 200 [iU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7SFC6U2VI5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308866 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 42023-205-01 Calcitonin Salmon 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 8 42023-205-01 Calcitonin Salmon 1 in 1 CARTON INJECTION, SOLUTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-205 CALCITONIN SALMON INJECTION, SOLUTION [ENDO USA, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240709_ece693d8-1832-4b85-8736-819163ba56c1.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 Marketing start Marketing end Sample Exclude flag Status 42023-205-01 42023020501 1 VIAL, MULTI-DOSE in 1 CARTON (42023-205-01) / 2 mL in 1 VIAL, MULTI-DOSE 2021-11-10 0000-00-00 No No Current