Ertapenem
- Product NDC
- 44647-051
- 11-digit product format
- 446470051
- Labeler code
- 44647
- Product ID
- 44647-051_0b211a36-8d30-fb5e-e063-6294a90af3de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ertapenem Sodium
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Savior Lifetec Corporation
- Application
- ANDA207647
- Marketing category
- ANDA
- Marketing start
- 2019-03-19
- Substance
- ERTAPENEM SODIUM
- Active strength
- 1 g/20mL
- Pharmacologic classes
- Carbapenems [CS], Penem Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ertapenem
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ERTAPENEM SODIUM | 1 g/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2T90KE67L0 |
| Rxcui | 1734683 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44647-051-01 | Ertapenem | 20 mL in 1 VIAL | INJECTION | 20 | | 14 |
| 44647-051-10 | Ertapenem | 10 in 1 CARTON | INJECTION | 10 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44647-051 | ERTAPENEM (ERTAPENEM SODIUM) INJECTION [SAVIOR LIFETEC CORPORATION] | 14 | Current NDC, Legacy NDC, 2 package rows | 20231128_c4da28cb-6725-4fa1-a7b0-e84f408fb36b.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 |
|---|
| 44647-051-01 | 44647005101 | 20 mL in 1 VIAL | 20 ml | | | | | Historical |
| 44647-051-10 | 44647005110 | 10 VIAL in 1 CARTON (44647-051-10) / 20 mL in 1 VIAL (44647-051-01) | 10 vial | 2019-03-19 | 0000-00-00 | No | No | Current |