cyanocobalamin NDC 45802-491

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-491Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0491Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
45802-491-84	45802049184	4 BOTTLE, UNIT-DOSE in 1 CARTON (45802-491-84) / 1 SPRAY in 1 BOTTLE, UNIT-DOSEMarketed from Dec 28, 2023

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
Route: Nasal
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212458
Marketing start: Dec 28, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Vitamin B 12 (Chemical structure)
Identifiers: Product ID 45802-491_4cf650d9-6d6c-4112-88f2-cd2e94f1f416SPL ID 4cf650d9-6d6c-4112-88f2-cd2e94f1f416SPL set ID 971e5f30-55c2-4193-9dd8-b43a1862b92aRxCUI 861113UNII P6YC3EG204
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

N445802049184 followed by a unit qualifier and the quantity

Package 45802-0491-84. 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 Feb 28, 2023.

Indications (excerpt from the label)

Cyanocobalamin Nasal Spray is indicated for: • Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement • Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia • Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 requirements in excess of normal Limitations of Use • Cyanocobalamin Nasal Spray should not be used for the vitamin B 12 absorption test (Schilling test). • In patients with correctible or temporary causes of vitamin B 12 deficiency, the benefit of continued…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)