Prescription drug · ANDA
Calcitonin Salmon NDC 49884-161
Calcitonin salmon 200 [iU]/.09mL · Spray, Metered · Nasal · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-161-11 | 49884016111 | 3.7 mL in 1 BOTTLE, GLASS (49884-161-11)Marketed from Jun 8, 2009 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Calcitonin Salmon
- Generic name (nonproprietary)
- calcitonin salmon
- Active ingredients
- Calcitonin salmon — 200 [iU]/.09mL
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076979
- Marketing start
- Listing expires
- Other FDA classes
- Calcitonin (Chemical structure)
- Identifiers
- Product ID 49884-161_0f4b56a3-ce50-41b6-985a-270bf416ffefSPL ID 0f4b56a3-ce50-41b6-985a-270bf416ffefSPL set ID a6eaedb3-5c96-4859-be43-a48c9c818bc7RxCUI 313919UNII 7SFC6U2VI5
- Pharmacologic class
- Calcitonin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N449884016111followed by a unit qualifier and the quantityPackage 49884-0161-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Calcitonin Salmon Nasal Solution is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated. ( 1.1 ) Limitations of Use: Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis. ( 1.2 , 5.4 ) Calcitonin Salmon Nasal Solution has not been shown to increase bone mineral density in early postmenopausal women ( 1.2 ) 1.1 Treatment of Postmenopausal Osteoporosis Calcitonin Salmon Nasal Solution is indicated for the treatment of postmenopausal o…
Excerpt only. Read the full label for complete information.