FDA.reportPublic FDA data

CALCITONIN SALMON injection, synthetic, for subcutaneous or intramuscular use

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-03-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:14:18

Label at a glance#

ProductCALCITONIN SALMON
Active ingredientCALCITONIN SALMON
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1971-1

Calcitonin Salmon Injection, USP, Synthetic

400 USP Units/2 mL (200 USP Units/mL)

For Intramuscular or Subcutaneous Use

2 mL Multiple-Dose vial

Rx only

vial label
vial label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308866calcitonin salmon 200 UNT/ML Injectable SolutionPSN1
308866salmon calcitonin 200 UNT/ML Injectable SolutionSCD1
308866calcitonin salmon 200 UNT/ML Injectable SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCITONIN SALMON Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70771-1971-1CALCITONIN SALMON2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21
70771-1971-1CALCITONIN SALMON1 in 1 CARTONINJECTION, SOLUTION11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-197170771-1971-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCITONIN SALMON7SFC6U2VI5ACTIB
ACETIC ACIDQ40Q9N063PIACT
PHENOL339NCG44TVIACT
SODIUM ACETATE4550K0SC9BIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215864-001CALCITONIN-SALMONCALCITONIN SALMON200 IU/MLINJECTABLE / INJECTIONAP2026-03-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A215864-001AP

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
2026-09-14 22:38:342026-08A215864-001CALCITONIN-SALMON200 IU/MLINJECTABLE / INJECTIONAP2026-03-0484e616aacf4f…
2026-08-18 06:07:402026-07A215864-001CALCITONIN-SALMON200 IU/MLINJECTABLE / INJECTIONAP2026-03-04caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215864-001CALCITONIN-SALMON200 IU/MLINJECTABLE / INJECTIONAP2026-03-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215864-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A215864-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215864-001AP1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CALCITONIN SALMONCALCITONIN SALMONZydus Lifesciences Limited6a0fdcc3-9dca-4936-8601-9ec87457263d2026-03-06Exact identifier
ndc (package): 70771-1971-1
ndc (product): 70771-1971
ndc11 (package): 70771197101
spl id: 6bd84678-423f-47bf-8e46-b128cc690af2
spl set id: 6a0fdcc3-9dca-4936-8601-9ec87457263d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.