Fortical

Product NDC
0245-0008
11-digit product format
002450008
Labeler code
0245
Product ID
0245-0008_2905a738-af8b-4baa-9c2f-67769897220c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcitonin salmon
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Upsher-Smith Laboratories, Inc.
Application
NDA021406
Marketing category
NDA
Marketing start
2005-08-12
Marketing end
0000-00-00
Substance
CALCITONIN SALMON
Active strength
2200 [iU]/mL
Pharmacologic classes
Calcitonin [CS],Calcitonin [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0245-0008DDiscontinued by firm2026-08-17
excluded packagepackage0245-00080245-0008-35DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0245-0008-35d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0245-0008-35f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0245-0008-352ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0245-0008-35a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0245-0008-35cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0245-0008-35cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0245-0008-35302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0245-0008-35ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0245-0008-350efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0245-0008-35ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0245-0008-35367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0245-0008-35557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021406-001FORTICALCALCITONIN SALMON RECOMBINANT200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021406-001FORTICAL200 IU/SPRAYSPRAY, METERED / NASAL2005-08-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021406-001FORTICAL200 IU/SPRAYSPRAY, METERED / NASAL2005-08-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-123f01610625f2…
2019-09-15 20:21 UTC2019-09N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SPRAY, METERED / NASAL2005-08-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021406-00164403922021-02-02U-227Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021406-001RE408122021-02-02Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021406-001RE435802021-02-02U-227Drug product2013-04-2674a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021406-00164403922021-02-02U-227Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021406-001RE408122021-02-02Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021406-001RE435802021-02-02U-227Drug product2013-04-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021406-00164403922021-02-02U-227Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021406-001RE408122021-02-02Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021406-001RE435802021-02-02U-227Drug product2013-04-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N021406-00164403922021-02-02U-227Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021406-001RE408122021-02-02Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021406-001RE435802021-02-02U-227Drug product2013-04-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021406-00164403922021-02-02U-227Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021406-001RE408122021-02-02Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021406-001RE435802021-02-02U-227Drug product2013-04-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021406-00164403922021-02-02U-227Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021406-001RE408122021-02-02Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021406-001RE435802021-02-02U-227Drug product2013-04-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021406-00164403922021-02-02U-227Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021406-001RE408122021-02-02Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021406-001RE435802021-02-02U-227Drug product2013-04-263f01610625f2…
2019-09-15 20:21 UTC2019-09N021406-00164403922021-02-02U-227Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021406-001RE408122021-02-02Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021406-001RE435802021-02-02U-227Drug product2013-04-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N021406-00164403922021-02-02U-227Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021406-001RE408122021-02-02Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021406-001RE435802021-02-02U-227Drug product2013-04-26ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0008-35ML - Milliliter0245-0008c8e27b06-f22c-4da5-9236-dccda029510d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
calcitonin salmonACTIVE INGREDIENT7SFC6U2VI5FORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
calcitonin salmonACTIVE MOIETY7SFC6U2VI5FORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHFORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
hydrochloric acidINACTIVE INGREDIENTQTT17582CBFORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
phenylethyl alcoholINACTIVE INGREDIENTML9LGA7468FORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XFORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
sodium hydroxideINACTIVE INGREDIENT55X04QC32IFORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
waterINACTIVE INGREDIENT059QF0KO0RFORTICAL (CALCITONIN SALMON) SPRAY, METERED [UPSHER-SMITH LABORATORIES, INC.]10
CALCITONIN SALMONACTIVE INGREDIENT7SFC6U2VI5FORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
CALCITONIN SALMONACTIVE MOIETY7SFC6U2VI5FORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
PHENETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFORTICAL (CALCITONIN SALMON) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1