Prescription drug · ANDA
Cyanocobalamin NDC 69680-121
Cyanocobalamin 1000 ug/mL · Injection, Solution · Intramuscular · Vitruvias Therapeutics
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69680-121-05 | 6968001210569680012105 | 5 VIAL, MULTI-DOSE in 1 BOX (69680-121-05) / 30 mL in 1 VIAL, MULTI-DOSEMarketed from Feb 12, 2020 | |
| 69680-121-10 | 6968001211069680012110 | 10 VIAL, MULTI-DOSE in 1 BOX (69680-121-10) / 30 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 15, 2021 | |
| 69680-121-30 | 6968001213069680012130 | 1 VIAL, MULTI-DOSE in 1 BOX (69680-121-30) / 30 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 15, 2021 |
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
- Vitruvias TherapeuticsNDC labeler code 69680
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209255
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin B 12 (Chemical structure)
- Identifiers
- Product ID 69680-121_7c3b0e85-bd17-4998-aaf4-1a873a357ab4SPL ID 7c3b0e85-bd17-4998-aaf4-1a873a357ab4SPL set ID 2117af8a-723f-4e2f-98a6-83ad2c423751RxCUI 309594UNII 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 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
N469680012105followed by a unit qualifier and the quantityPackage 69680-0121-05. 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 B12 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.
About NDC 69680-121
- What is NDC 69680-121?
- 69680-121 is the product NDC for Cyanocobalamin, Cyanocobalamin 1000 ug/mL injection, solution, listed with the FDA by Vitruvias Therapeutics. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyanocobalamin.
- What is the active ingredient?
- Cyanocobalamin.
- Who is the labeler?
- Vitruvias Therapeutics, NDC labeler code 69680. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyanocobalamin?
- 50 other product NDCs are listed under this name. See all Cyanocobalamin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyanocobalamin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular, Subcutaneous | Lifestar Pharma LLC | 70756-637 | 70756-0637-0570756-0637-1070756-0637-88 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular, Subcutaneous | Henry Schein, Inc. | 0404-9783 | 00404-9783-30 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular | Henry Schein, Inc. | 0404-9786 | 00404-9786-10 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular, Subcutaneous | BluePoint Laboratories | 68001-640 | 68001-0640-60 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-300 | 71288-0300-02 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-301 | 71288-0301-11 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | InjectionIntramuscular, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-302 | 71288-0302-30 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular, Subcutaneous | NorthStar RxLLC | 72603-650 | 72603-0650-25 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular, Subcutaneous | Lifestar Pharma LLC | 70756-635 | 70756-0635-1070756-0635-25 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular, Subcutaneous | Lifestar Pharma LLC | 70756-636 | 70756-0636-1070756-0636-25 |
Other NDCs under ANDA 209255
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 | Injection, SolutionIntramuscular | Henry Schein, Inc. | 0404-9786 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular | A-S Medication Solutions | 50090-6229 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular | Vitruvias Therapeutics | 69680-112 |
| Cyanocobalamin | Cyanocobalamin 1000 ug/mL | Injection, SolutionIntramuscular | Vitruvias Therapeutics | 69680-113 |