propofol
- Product NDC
- 71288-731
- 11-digit product format
- 712880731
- Labeler code
- 71288
- Product ID
- 71288-731_98e25b4f-43c4-4269-8213-aacb02a75099
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propofol
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA217945
- Marketing category
- ANDA
- Marketing start
- 2025-12-02
- Substance
- PROPOFOL
- Active strength
- 10 mg/mL
- Pharmacologic classes
- General Anesthesia [PE], General Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- propofol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPOFOL | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YI7VU623SF |
| Rxcui | 1808217, 1808222, 1808224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-731-52 | propofol | 100 mL in 1 VIAL | INJECTION, EMULSION | 100 | | 3 |
| 71288-731-53 | propofol | 10 in 1 CARTON | INJECTION, EMULSION | 10 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-731-52 | 71288073152 | 100 mL in 1 VIAL | 100 ml | | | | Historical |
| 71288-731-53 | 71288073153 | 10 VIAL in 1 CARTON (71288-731-53) / 100 mL in 1 VIAL (71288-731-52) | 10 vial | 2025-12-02 | No | No | Historical |