Prescription drug · ANDA
Cidofovir (Cidofovir anhydrous) NDC 67457-210
Cidofovir 75 mg/mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-210-05 | 67457021005 | 1 VIAL, GLASS in 1 CARTON (67457-210-05) / 5 mL in 1 VIAL, GLASSMarketed from Jun 3, 2013 |
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)
- Cidofovir
- Generic name (nonproprietary)
- cidofovir anhydrous
- Active ingredients
- Cidofovir — 75 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201276
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 67457-210_e7774227-c6ba-439d-a32f-01b67d010fc5SPL ID e7774227-c6ba-439d-a32f-01b67d010fc5SPL set ID 56541229-8c1a-4550-8951-2415ed08e7e9RxCUI 199388UNII JIL713Q00N
- Pharmacologic class
- Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
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
N467457021005followed by a unit qualifier and the quantityPackage 67457-0210-05. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.
Excerpt only. Read the full label for complete information.
About NDC 67457-210
- What is NDC 67457-210?
- 67457-210 is the product NDC for Cidofovir (cidofovir anhydrous), Cidofovir 75 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cidofovir (Cidofovir Anhydrous).
- What is the active ingredient?
- Cidofovir.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cidofovir?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.