calcitonin salmon

Product NDC
0781-6320
11-digit product format
007816320
Labeler code
0781
Product ID
0781-6320_99e9e62b-9796-42ec-8f69-551dabf92ec1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcitonin salmon
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Sandoz Inc
Application
NDA020313
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1995-08-01
Marketing end
0000-00-00
Substance
CALCITONIN SALMON
Active strength
200 [iU]/1
Pharmacologic classes
Calcitonin [CS],Calcitonin [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-6320DDiscontinued by firm2026-07-31
excluded packagepackage0781-63200781-6320-79DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020313-002MIACALCINCALCITONIN SALMON200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-08-17

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6320-79ML - Milliliter0781-63208c3a8fba-d435-46aa-b709-1c17fbe3cab412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITONIN SALMONACTIVE INGREDIENT7SFC6U2VI5CALCITONIN SALMON SPRAY, METERED [SANDOZ INC]5
CALCITONIN SALMONACTIVE MOIETY7SFC6U2VI5CALCITONIN SALMON SPRAY, METERED [SANDOZ INC]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CALCITONIN SALMON SPRAY, METERED [SANDOZ INC]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCALCITONIN SALMON SPRAY, METERED [SANDOZ INC]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCALCITONIN SALMON SPRAY, METERED [SANDOZ INC]5
WATERINACTIVE INGREDIENT059QF0KO0RCALCITONIN SALMON SPRAY, METERED [SANDOZ INC]5