MEROPENEM
- Product NDC
- 70594-075
- 11-digit product format
- 705940075
- Labeler code
- 70594
- Product ID
- 70594-075_3ee484ef-4e7f-464a-ac2e-7963d9dc5df6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MEROPENEM
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Xellia Pharmaceuticals USA LLC
- Application
- ANDA206141
- Marketing category
- ANDA
- Marketing start
- 2021-06-28
- Substance
- MEROPENEM
- Active strength
- 500 mg/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
- MEROPENEM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEROPENEM | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FV9J3JU8B1 |
| Rxcui | 1722934, 1722939 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70594-075-01 | MEROPENEM | 1 in 1 VIAL, GLASS | INJECTION, POWDER, FOR SOLUTION | 1 | | 7 |
| 70594-075-02 | MEROPENEM | 10 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70594-075 | MEROPENEM INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241211_06d84c55-94ff-46e5-8477-b8881c12eb0a.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 |
|---|
| 70594-075-01 | 70594007501 | 1 in 1 VIAL, GLASS | | | | | Historical |
| 70594-075-02 | 70594007502 | 10 VIAL, GLASS in 1 CARTON (70594-075-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-075-01) | 2021-06-28 | 0000-00-00 | No | No | Current |