Ertapenem
- Product NDC
- 55150-282
- 11-digit product format
- 551500282
- Labeler code
- 55150
- Product ID
- 55150-282_250abb8f-6547-4f69-94c3-87917dc34240
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ertapenem
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA209133
- Marketing category
- ANDA
- Marketing start
- 2018-06-25
- 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 |
|---|
| 55150-282-20 | Ertapenem | 10 in 1 CARTON | INJECTION | 10 | | 10 |
| 55150-282-20 | Ertapenem | 1 in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 10 |
| 55150-282-09 | Ertapenem | 1 in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 7 |
| 55150-282-09 | Ertapenem | 10 in 1 CARTON | INJECTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-282 | ERTAPENEM INJECTION [EUGIA US LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240710_f725a68c-31a2-482a-9744-19adc47506b5.zip |
| 55150-282 | ERTAPENEM INJECTION [EUGIA US LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240710_31bcf16f-e0c1-47d1-9852-de898a856f6e.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 |
|---|
| 55150-282-09 | 55150028209 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-09) / 1 INJECTION in 1 VIAL, SINGLE-DOSE | 2018-06-25 | 0000-00-00 | No | No | Current |
| 55150-282-20 | 55150028220 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20) / 1 INJECTION in 1 VIAL, SINGLE-DOSE | 2018-06-25 | 0000-00-00 | No | No | Current |