Calcitonin Salmon

Product NDC
43598-051
11-digit product format
435980051
Labeler code
43598
Product ID
43598-051_621ce5a0-32c4-a1fc-1e71-a9da8b50212f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitonin Salmon
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA215715
Marketing category
ANDA
Marketing start
2024-06-17
Substance
CALCITONIN SALMON
Active strength
200 [USP'U]/mL
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCITONIN SALMON200 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SFC6U2VI5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ae5d83d-b2bd-30a6-654a-2c8aed49ff95Product name320250130
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
5fa4b33f-5167-4398-beb0-63a0d0d1dc17Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-051-11Calcitonin Salmon2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION23
43598-051-11Calcitonin Salmon1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-051-11ML - Milliliter43598-0513487145e-e48c-4542-9cf7-ad90605c189a12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-051CALCITONIN SALMON INJECTION, SOLUTION [DR. REDDY'S LABORATORIES, INC.]3Current NDC, 2 package rows20240617_26f19d56-44fd-dc7a-46e8-afaaaba5734f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308866calcitonin salmon 200 UNT/ML Injectable SolutionPSN26f19d56-44fd-dc7a-46e8-afaaaba5734f3
308866salmon calcitonin 200 UNT/ML Injectable SolutionSCD26f19d56-44fd-dc7a-46e8-afaaaba5734f3
308866calcitonin salmon 200 UNT/ML Injectable SolutionSY26f19d56-44fd-dc7a-46e8-afaaaba5734f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-051-11435980051111 VIAL, MULTI-DOSE in 1 CARTON (43598-051-11) / 2 mL in 1 VIAL, MULTI-DOSE2024-06-17NoNoHistorical