propofol
- Product NDC
- 16714-977
- 11-digit product format
- 167140977
- Labeler code
- 16714
- Product ID
- 16714-977_d7b2f7ed-e91e-430a-bab2-a9533b90e8b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propofol
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- NorthStar Rx LLC
- Application
- ANDA206408
- Marketing category
- ANDA
- Marketing start
- 2022-07-01
- 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 |
|---|
| 16714-977-01 | propofol | 50 mL in 1 VIAL | INJECTION, EMULSION | 50 | | 5 |
| 16714-977-20 | propofol | 20 in 1 CARTON | INJECTION, EMULSION | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-977 | PROPOFOL INJECTION, EMULSION [NORTHSTAR RX LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241207_5ec25932-6c21-4cd5-8f60-80761f2e20a6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-977-01 | 16714097701 | 50 mL in 1 VIAL | 50 ml | | | | | Historical |
| 16714-977-20 | 16714097720 | 20 VIAL in 1 CARTON (16714-977-20) / 50 mL in 1 VIAL (16714-977-01) | 20 vial | 2025-06-02 | 0000-00-00 | No | No | Current |