Prescription drug · ANDA
Cyanocobalamin NDC 43386-237
Cyanocobalamin 500 ug/1 · Spray, Metered · Nasal · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-237-60 | 43386023760 | 1 CARTON in 1 BLISTER PACK (43386-237-60) / 4 SPRAY, METERED in 1 CARTON (43386-237-70)Marketed from Jan 29, 2024 |
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)
- Cyanocobalamin
- Generic name (nonproprietary)
- cyanocobalamin
- Active ingredients
- Cyanocobalamin — 500 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Lupin Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210629
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin B 12 (Chemical structure)
- Identifiers
- Product ID 43386-237_bb7b94e1-b5cd-486f-9e34-38fc9595547aSPL ID bb7b94e1-b5cd-486f-9e34-38fc9595547aSPL set ID efb7dc02-f0c9-4537-9e23-b641c428068cRxCUI 861113UNII P6YC3EG204UPC 0343386237609
- Pharmacologic class
- Vitamin B12
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
N443386023760followed by a unit qualifier and the quantityPackage 43386-0237-60. 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)
Cyanocobalamin Nasal Spray is indicated for: Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal Limitations of Use: Cyanocobalamin Nasal Spray should not be used for the vitamin B12 absorption test (Schilling test). In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long term use o…
Excerpt only. Read the full label for complete information.