Prescription drug · ANDA
Propofol NDC 80830-1188
Propofol 10 mg/mL · Injection, Emulsion · Intravenous · Amneal Pharmaceuticals Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80830-1188-7 | 80830118807 | 10 VIAL in 1 CARTON (80830-1188-7) / 20 mL in 1 VIAL (80830-1188-1)Marketed from Aug 16, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Propofol
- Generic name (nonproprietary)
- propofol
- Active ingredients
- Propofol — 10 mg/mL
- Dosage form
- Injection, Emulsion
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217525
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 80830-1188_37f0add8-759a-4ec9-a147-edef685124e5SPL ID 37f0add8-759a-4ec9-a147-edef685124e5SPL set ID 6833edd6-ba8a-4b97-a872-ab253c64a903RxCUI 1808217, 1808222, 1808224UNII YI7VU623SFUPC 0380830118817, 0380830236573, 0380830236511, 0380830118879
- 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
N480830118807followed by a unit qualifier and the quantityPackage 80830-1188-07. 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)
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age. Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age. Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients. Sedation for Adult Patients in Combination with Regional Anesthesia. Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients. Limitations of Use : Propofol injectable emulsion is not recommended for induct…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217525
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.