ERTAPENEM
- Product NDC
- 42023-221
- 11-digit product format
- 420230221
- Labeler code
- 42023
- Product ID
- 42023-221_137f9963-a021-47a5-8bb0-2a1621030708
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ertapenem sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- ENDO USA, Inc.
- Application
- NDA021337
- Marketing category
- NDA
- Marketing start
- 2018-11-01
- Substance
- ERTAPENEM SODIUM
- Active strength
- 1 g/1
- Pharmacologic classes
- Carbapenems [CS], Penem Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ERTAPENEM
- Listing expiration
- 2027-12-31
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 |
|---|
| 42023-221-01 | ERTAPENEM | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 13 |
| 42023-221-10 | ERTAPENEM | 10 in 1 PACKAGE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 13 |
| 42023-221-85 | ERTAPENEM | 10 in 1 PACKAGE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 13 |
| 42023-221-89 | ERTAPENEM | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-221 | ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240716_657855f2-7c92-4aa8-9c3d-51d08e56a09a.zip |
| 42023-221 | ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240716_41304b1d-7db4-468a-ab1d-04e56fb50de4.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 |
|---|
| 42023-221-01 | 42023022101 | 1 in 1 VIAL, SINGLE-DOSE | | | | | Historical |
| 42023-221-10 | 42023022110 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01) | 2018-07-26 | 0000-00-00 | No | No | Current |
| 42023-221-85 | 42023022185 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-85) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-89) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 42023-221-89 | 42023022189 | 1 in 1 VIAL, SINGLE-DOSE | | | | | Historical |