Prescription drug · ANDA
Cyanocobalamin NDC 55150-364
Cyanocobalamin 1000 ug/mL · Injection, Solution · Intramuscular · AuroMedics Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-364-01 | 55150036401 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-364-01) / 1 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 8, 2020 | |
| 55150-364-10 | 55150036410 | 10 VIAL, MULTI-DOSE in 1 CARTON (55150-364-10) / 1 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 8, 2020 | |
| 55150-364-25 | 55150036425 | 25 VIAL, MULTI-DOSE in 1 CARTON (55150-364-25) / 1 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 8, 2020 |
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 — 1000 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- AuroMedics Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213874
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin B 12 (Chemical structure)
- Identifiers
- Product ID 55150-364_a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7SPL ID a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7SPL set ID db84d0ea-5c15-47f5-bbe2-8d455e75695eRxCUI 309594UNII P6YC3EG204UPC 0355150364015, 0355150364107
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N455150036401followed by a unit qualifier and the quantityPackage 55150-0364-01. 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)
INDICATIONS AND USAGE Cyanocobalamin is indicated for vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: • Addisonian (pernicious) anemia • Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy • Fish tapeworm infestation • Malignancy of pancreas or bowel • Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions ), use of a gluten-fr…
Excerpt only. Read the full label for complete information.