ertapenem sodium
- Product NDC
- 0143-9398
- 11-digit product format
- 001439398
- Labeler code
- 0143
- Product ID
- 0143-9398_0563c487-5b62-46fe-a7e3-8ade454f1f4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ertapenem sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA, Inc.
- Application
- ANDA208790
- Marketing category
- ANDA
- Marketing start
- 2021-08-02
- Substance
- ERTAPENEM SODIUM
- Active strength
- 1 g/1
- 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 sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ERTAPENEM SODIUM | 1 g/1 |
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 |
|---|
| 0143-9398-01 | ertapenem sodium | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 0143-9398-10 | ertapenem sodium | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9398 | ERTAPENEM SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241108_a400707f-763f-43f6-989e-0d2569d822d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9398-01 | 00143939801 | 1 in 1 VIAL, SINGLE-DOSE | | | | | Historical |
| 0143-9398-10 | 00143939810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01) | 2021-08-02 | 0000-00-00 | No | No | Current |