Ertapenem
- Product NDC
- 0409-3510
- 11-digit product format
- 004093510
- Labeler code
- 0409
- Product ID
- 0409-3510_7dea65ba-ff7e-445b-972e-c972c3140d91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ertapenem
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA208790
- Marketing category
- ANDA
- Marketing start
- 2020-10-19
- 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
- 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 |
|---|
| 0409-3510-21 | Ertapenem | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 0409-3510-22 | Ertapenem | 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 |
|---|
| 0409-3510 | ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241108_178a0356-4f6c-47fb-9913-f325a3c72f7b.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 |
|---|
| 0409-3510-21 | 00409351021 | 1 in 1 VIAL, SINGLE-DOSE | | | | | Historical |
| 0409-3510-22 | 00409351022 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3510-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-3510-21) | 2020-10-19 | 0000-00-00 | No | No | Current |