Calcitonin Salmon
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . nasal sprayInitial U.S. Approval: 1975
c82eb602-12e1-692b-d660-f8d5b5736b54
HUMAN PRESCRIPTION DRUG LABEL
Sep 17, 2025
Apotex Corp.
DUNS: 845263701
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcitonin Salmon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - PACKAGE CARTON LABEL
**APOTEX CORP.**NDC 60505-0823-6
Calcitonin Salmon (synthetic origin) Nasal Spray
** (Calcitonin Salmon Nasal Solution, USP)**
Rx
30 Doses per bottle
2200 USP Calcitonin Salmon Units/mL (200 USP Calcitonin Salmon Units/spray)
FOR INTRANASAL USE ONLY
REFRIGERATE UNTIL OPENED
SPL UNCLASSIFIED SECTION
INSTRUCTIONS FOR USE
Calcitonin Salmon (synthetic origin)
(kal" si toe' nin)
Nasal Spray
For Nasal Use Only.
Important information about your Calcitonin Salmon (synthetic origin) Nasal Spray:
- A single spray of Calcitonin Salmon (synthetic origin) Nasal Spray contains 1 daily dose of medicine.
- Each Calcitonin Salmon (synthetic origin) Nasal Spray bottle contains the right amount of medicine. The bottle may not be completely filled to the top. This is normal.
- This package contains 1 bottle of Calcitonin Salmon (synthetic origin) Nasal Spray with attached pump.
- Store unopened bottles of Calcitonin Salmon (synthetic origin) Nasal Spray in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze.
- After you open your bottle of Calcitonin Salmon (synthetic origin) Nasal Spray, store it at room temperature between 20°C to 25°C (68°F to 77°F) in an upright position. Do not shake the bottle.
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Preparing your Calcitonin Salmon (synthetic origin) Nasal Spray: | |
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**Step 1.**Remove the bottle from your refrigerator and let it reach room temperature. Check the medicine in the bottle to make sure it is clear and colorless without particles. | |
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Step 2. Remove the clear plastic dust cap and the blue safety clip from the nasal spray pump.See Figure 1. The safety clip prevents the accidental discharge of the spray in your pocket or purse. |
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Step 3. Check to see if your Calcitonin Salmon (synthetic origin) Nasal Spray has been primed.
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Step 4. Priming your Calcitonin Salmon (synthetic origin) Nasal Spray:
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Giving your Calcitonin Salmon (synthetic origin) Nasal Spray dose: | |
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Step 5. Insert the nasal spray pump in 1 side of your nose.See Figure 3.
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Step 6. Firmly press down on the nose spray pump to release the medicine. See Figure 4.
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Cleaning your Calcitonin Salmon (synthetic origin) Nasal Spray pump: | |
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Step 7. Wipe the nose spray pump with a clean, damp cloth 1 to 2 times a week.See Figure 5.
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Storing your Calcitonin Salmon (synthetic origin) Nasal Spray: | |
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Step 8. Replace the blue safety clip, then replace the protective cap on the nasal spray unit.See Figure 6.
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When should I throw away Calcitonin Salmon (synthetic origin) Nasal Spray?
- Unopened, refrigerated bottles can be used until the expiration date stamped on the bottle and box.
- Throw away Calcitonin Salmon (synthetic origin) Nasal Spray after you use 14 doses (2 mL fill) or 30 doses (3.7 mL fill) (sprays).
- Throw away Calcitonin Salmon (synthetic origin) Nasal Spray bottles left at room temperature (opened or unopened) for more than 30 days (2 mL fill) or 35 days (3.7 mL fill).
For more information on Calcitonin Salmon (synthetic origin) Nasal Spray, call Apotex Corp. at 1-800-706-5575.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
APOTEX INC.
CALCITONIN SALMON (SYNTHETIC ORIGIN) NASAL SPRAY
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Manufactured by |
Manufactured for |
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Apotex Inc. |
Apotex Corp. |
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Toronto, Ontario |
Weston, FL |
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Canada M9L 1T9 |
33326 |
Revised: November 2017
DESCRIPTION SECTION
11 DESCRIPTION
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.
Calcitonin Salmon (synthetic origin) Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula:
It is provided in a 2 mL or 3.7 mL fill glass bottle as a solution for nasal administration. This is sufficient medication for at least 14 doses (2 mL fill) or 30 doses (3.7 mL fill).
Active Ingredient: calcitonin salmon 2200 USP Calcitonin Salmon Units per mL (corresponding to 200 USP Calcitonin Salmon Units per 0.09 mL actuation).
Inactive Ingredients: benzalkonium chloride, hydrochloric acid (added as necessary to adjust pH), purified water and sodium chloride.
The activity of calcitonin salmon nasal spray is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin salmon for Bioassay, distributed by the National Institute of Biological Standards and Control, Holly Hill, London.