Prescription drug · NDA
Diprivan (Propofol) NDC 65219-800
Propofol 10 mg/mL · Injection, Emulsion · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-800-10 | 6521908001065219080010 | 10 VIAL in 1 CARTON (65219-800-10) / 20 mL in 1 VIAL (65219-800-01)Marketed from Jan 13, 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)
- Diprivan
- Generic name (nonproprietary)
- propofol
- Active ingredients
- Propofol — 10 mg/mL
- Dosage form
- Injection, Emulsion
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019627
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 65219-800_8d8838c0-3c0c-4732-ade1-12f76001c50bSPL ID 8d8838c0-3c0c-4732-ade1-12f76001c50bSPL set ID 5cec3b97-5183-4a9d-accd-21e76c99d3ddRxCUI 1808224, 1808225UNII YI7VU623SFUPC 0365219800019
- Pharmacologic class
- General Anesthetic
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
N465219080010followed by a unit qualifier and the quantityPackage 65219-0800-10. 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: DIPRIVAN is an IV general anesthetic and sedation drug that can be used as described in the table below. Table 3. Indications for DIPRIVAN Indication Approved Patient Population Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation Adults only Combined sedation and regional anesthesia Adults only (see PRECAUTIONS ) Induction of General Anesthesia Patients greater than or equal to 3 years of age Maintenance of General Anesthesia Patients greater than or equal to 2 months of age Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients Adults only Safety, effectiveness and dosing guidelines for DIPRIVAN have not been established f…
Excerpt only. Read the full label for complete information.
About NDC 65219-800
- What is NDC 65219-800?
- 65219-800 is the product NDC for Diprivan (propofol), Propofol 10 mg/mL injection, emulsion, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diprivan (Propofol).
- What is the active ingredient?
- Propofol.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diprivan?
- 1 other product NDC are listed under this name. See all Diprivan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diprivan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diprivanpropofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Fresenius Kabi USA, LLC | 63323-269 | 63323-0269-1063323-0269-2963323-0269-50+1 more |
Other NDCs under NDA 019627
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 |
|---|---|---|---|---|
| Diprivanpropofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Fresenius Kabi USA, LLC | 63323-269 |