Prescription drug · ANDA
Calcitonin Salmon NDC 60505-0823
Calcitonin salmon 200 [iU]/1 · Spray, Metered · Nasal · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0823-0 | 60505082300 | 1 BOTTLE, GLASS in 1 CARTON (60505-0823-0) / 14 SPRAY, METERED in 1 BOTTLE, GLASSMarketed from Dec 9, 2008 | |
| 60505-0823-6 | 60505082306 | 1 BOTTLE, GLASS in 1 CARTON (60505-0823-6) / 30 SPRAY, METERED in 1 BOTTLE, GLASSMarketed from Dec 9, 2008 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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]/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076396
- Marketing start
- Listing expires
- Other FDA classes
- Calcitonin (Chemical structure)
- Identifiers
- Product ID 60505-0823_cfb1e095-a992-4ea0-dc4e-54b0b8ecb3acSPL ID cfb1e095-a992-4ea0-dc4e-54b0b8ecb3acSPL set ID c82eb602-12e1-692b-d660-f8d5b5736b54RxCUI 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
N460505082300followed by a unit qualifier and the quantityPackage 60505-0823-00. 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 (synthetic origin) Nasal Spray 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 spray has not been shown to increase bone mineral density in early postmenopausal women ( 1.2 ) 1.1 Treatment of Postmenopausal Osteoporosis Calcitonin Salmon (synthetic origin) Nasal Spray is indicated for the tr…
Excerpt only. Read the full label for complete information.