FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Calcitonin Salmon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCITONIN SALMON200 [iU]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SFC6U2VI5
Rxcui313919

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ae5d83d-b2bd-30a6-654a-2c8aed49ff95Product name320250130
5fa4b33f-5167-4398-beb0-63a0d0d1dc17Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0823-0Calcitonin Salmon1 in 1 CARTONSPRAY, METERED113
60505-0823-0Calcitonin Salmon14 in 1 BOTTLE, GLASSSPRAY, METERED1413
60505-0823-6Calcitonin Salmon30 in 1 BOTTLE, GLASSSPRAY, METERED3013
60505-0823-6Calcitonin Salmon1 in 1 CARTONSPRAY, METERED113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0823-6ML - Milliliter60505-0823fb4a2830-ff39-4fbc-88c9-c89f2732b37412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITONIN SALMONACTIVE INGREDIENT7SFC6U2VI5CALCITONIN SALMON SPRAY, METERED [APOTEX CORP.]6
CALCITONIN SALMONACTIVE MOIETY7SFC6U2VI5CALCITONIN SALMON SPRAY, METERED [APOTEX CORP.]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CALCITONIN SALMON SPRAY, METERED [APOTEX CORP.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCALCITONIN SALMON SPRAY, METERED [APOTEX CORP.]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCALCITONIN SALMON SPRAY, METERED [APOTEX CORP.]6
WATERINACTIVE INGREDIENT059QF0KO0RCALCITONIN SALMON SPRAY, METERED [APOTEX CORP.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0823CALCITONIN SALMON SPRAY, METERED [APOTEX CORP.]12Current NDC, Legacy NDC, 4 package rows20240922_c82eb602-12e1-692b-d660-f8d5b5736b54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313919calcitonin salmon 200 UNT/ACTUAT Nasal SprayPSNc82eb602-12e1-692b-d660-f8d5b5736b5413
313919salmon calcitonin 200 UNT/ACTUAT Nasal SpraySCDc82eb602-12e1-692b-d660-f8d5b5736b5413
313919calcitonin salmon 200 UNT/ACTUAT (2200 UNT/ML) Nasal SpraySYc82eb602-12e1-692b-d660-f8d5b5736b5413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0823-0605050823001 BOTTLE, GLASS in 1 CARTON (60505-0823-0) / 14 SPRAY, METERED in 1 BOTTLE, GLASS2008-12-090000-00-00NoNoCurrent
60505-0823-6605050823061 BOTTLE, GLASS in 1 CARTON (60505-0823-6) / 30 SPRAY, METERED in 1 BOTTLE, GLASS2008-12-090000-00-00NoNoCurrent