Prescription drug · ANDA
propofol NDC 25021-608
Propofol 10 mg/mL · Injection, Emulsion · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-608-20 | 2502106082025021060820 | 25 VIAL in 1 CARTON (25021-608-20) / 20 mL in 1 VIALMarketed from Jul 1, 2014 | |
| 25021-608-50 | 2502106085025021060850 | 20 VIAL in 1 CARTON (25021-608-50) / 50 mL in 1 VIALMarketed from Jul 1, 2014 | |
| 25021-608-51 | 2502106085125021060851 | 10 VIAL in 1 CARTON (25021-608-51) / 100 mL in 1 VIALMarketed from Jul 1, 2014 |
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)
- propofol
- Generic name (nonproprietary)
- propofol
- Active ingredients
- Propofol — 10 mg/mL
- Dosage form
- Injection, Emulsion
- Route
- Intravenous
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075102
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 25021-608_24f96546-ad32-43ca-be91-5536e26d4137SPL ID 24f96546-ad32-43ca-be91-5536e26d4137SPL set ID fa93f173-7858-4d88-860e-76ab97e65c2fRxCUI 1808217, 1808222, 1808224UNII YI7VU623SF
- 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
N425021060820followed by a unit qualifier and the quantityPackage 25021-0608-20. 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: 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 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…
Excerpt only. Read the full label for complete information.
About NDC 25021-608
- What is NDC 25021-608?
- 25021-608 is the product NDC for propofol, Propofol 10 mg/mL injection, emulsion, listed with the FDA by Sagent Pharmaceuticals. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- propofol.
- What is the active ingredient?
- Propofol.
- Who is the labeler?
- Sagent Pharmaceuticals, NDC labeler code 25021. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for propofol?
- 29 other product NDCs are listed under this name. See all propofol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other propofol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Hospira, Inc. | 0409-0010 | 00409-0010-98 |
| Propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Hospira, Inc. | 0409-0501 | 00409-0501-98 |
| Propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Hospira, Inc. | 0409-1511 | 00409-1511-98 |
| Propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Anthea Pharma Private Limited | 83854-018 | 83854-0018-1083854-0018-1483854-0018-15+1 more |
| propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-729 | 71288-0729-21 |
| propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-730 | 71288-0730-51 |
| propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-731 | 71288-0731-53 |
| Propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Avenacy, LLC | 83634-603 | 83634-0603-2083634-0603-5083634-0603-51 |
| Propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-1188 | 80830-1188-07 |
| Propofol | Propofol 10 mg/mL | Injection, EmulsionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2364 | 80830-2364-08 |