FDA.reportPublic FDA data

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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0245-0008DDiscontinued by firm2026-07-31
excluded packagepackage0245-00080245-0008-35DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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SALMON RECOMBINANT200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021406-001FORTICAL200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASAL2005-08-12a50c72e98297…

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