Propofol Injectable Emulsion
- Product NDC
- 43598-548
- 11-digit product format
- 435980548
- Labeler code
- 43598
- Product ID
- 43598-548_b4a9147e-dfe3-229a-d8d7-6a84e6449f15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propofol Injectable Emulsion
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- Dr. Reddy's Laboratories, Inc.
- Application
- ANDA205067
- Marketing category
- ANDA
- Marketing start
- 2018-11-15
- 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 Injectable Emulsion
- 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 |
|---|
| 43598-548-21 | Propofol Injectable Emulsion | 20 in 1 CARTON | INJECTION, EMULSION | 20 | | 5 |
| 43598-548-50 | Propofol Injectable Emulsion | 50 mL in 1 VIAL | INJECTION, EMULSION | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-548 | PROPOFOL INJECTABLE EMULSION INJECTION, EMULSION [DR. REDDY'S LABORATORIES, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230401_800646b8-83a8-01d9-3dc8-bb2ddcb8570c.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 |
|---|
| 43598-548-21 | 43598054821 | 20 VIAL in 1 CARTON (43598-548-21) / 50 mL in 1 VIAL (43598-548-50) | 20 vial | 2018-11-15 | 0000-00-00 | No | No | Current |
| 43598-548-50 | 43598054850 | 50 mL in 1 VIAL | 50 ml | | | | | Historical |