Home NDC 60505-0823 Calcitonin Salmon
Product NDC 60505-0823
11-digit product format 605050823
Labeler code 60505
Product ID 60505-0823_8171dcb4-228d-74b1-cd95-4abb874d2806
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitonin Salmon
Dosage form SPRAY, METERED
Route NASAL
Labeler Apotex Corp.
Application ANDA076396
Marketing category ANDA
Marketing start 2008-12-09
Substance CALCITONIN SALMON
Active strength 200 [iU]/1
Pharmacologic classes Calcitonin [CS], Calcitonin [EPC]
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 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 A076396-001 CALCITONIN-SALMON CALCITONIN SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076396-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL AB RS 2008-11-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076396-001 CALCITONIN-SALMON 200 IU/SPRAY SPRAY, METERED / NASAL RS 2008-11-17 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Calcitonin Salmon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCITONIN SALMON 200 [iU]/1
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 313919 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 60505-0823-0 Calcitonin Salmon 1 in 1 CARTON SPRAY, METERED 1 13 60505-0823-0 Calcitonin Salmon 14 in 1 BOTTLE, GLASS SPRAY, METERED 14 13 60505-0823-6 Calcitonin Salmon 30 in 1 BOTTLE, GLASS SPRAY, METERED 30 13 60505-0823-6 Calcitonin Salmon 1 in 1 CARTON SPRAY, METERED 1 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0823 CALCITONIN SALMON SPRAY, METERED [APOTEX CORP.] 12 Current NDC, Legacy NDC, 4 package rows 20240922_c82eb602-12e1-692b-d660-f8d5b5736b54.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 60505-0823-0 60505082300 1 BOTTLE, GLASS in 1 CARTON (60505-0823-0) / 14 SPRAY, METERED in 1 BOTTLE, GLASS 2008-12-09 0000-00-00 No No Current 60505-0823-6 60505082306 1 BOTTLE, GLASS in 1 CARTON (60505-0823-6) / 30 SPRAY, METERED in 1 BOTTLE, GLASS 2008-12-09 0000-00-00 No No Current