Prescription drug · ANDA
Cyanocobalamin NDC 0143-9621
Cyanocobalamin 1000 ug/mL · Injection · Intramuscular, Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9621-25 | 00143962125 | 25 VIAL in 1 BOX (0143-9621-25) / 1 mL in 1 VIAL (0143-9621-01)Marketed from Oct 20, 1971 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080515
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin B 12 (Chemical structure)
- Identifiers
- Product ID 0143-9621_58925d4c-edff-43c6-9c9b-07102e84e41fSPL ID 58925d4c-edff-43c6-9c9b-07102e84e41fSPL set ID a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6RxCUI 309594UNII P6YC3EG204UPC 0301439620105
- 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
N400143962125followed by a unit qualifier and the quantityPackage 00143-9621-25. 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
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-free diet in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 080515
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 | Hikma Pharmaceuticals USA Inc. | 0143-9619 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9620 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1394 |