Prescription drug · ANDA
Cyanocobalamin NDC 68083-449
Cyanocobalamin 1000 ug/mL · Injection · Intramuscular, Subcutaneous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-449-25 | 68083044925 | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-449-25) / 1 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 24, 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
- Route
- Intramuscular, Subcutaneous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214390
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin B 12 (Chemical structure)
- Identifiers
- Product ID 68083-449_771cf601-8f92-4e4f-a29f-b18e71b1ba96SPL ID 771cf601-8f92-4e4f-a29f-b18e71b1ba96SPL set ID cd8d188a-fa5d-4580-bcb1-ac8617118cbbRxCUI 309594UNII P6YC3EG204UPC 0368083449254
- 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
N468083044925followed by a unit qualifier and the quantityPackage 68083-0449-25. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 214390
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-303 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-303 |
| cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Gland Pharma Limited | 68083-561 |
| cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Gland Pharma Limited | 68083-562 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Plano Pharmaceuticals Inc. | 87188-111 |
| cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Plano Pharmaceuticals Inc. | 87188-112 |
| cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Plano Pharmaceuticals Inc. | 87188-113 |