Meropenem
- Product NDC
- 68083-146
- 11-digit product format
- 680830146
- Labeler code
- 68083
- Product ID
- 68083-146_3a747235-2a80-4d63-bbbf-d81538daf99a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meropenem
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA206141
- Marketing category
- ANDA
- Marketing start
- 2017-04-28
- Substance
- MEROPENEM
- Active strength
- 500 mg/20mL
- 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/20mL |
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 |
|---|
| 68083-146-10 | Meropenem | 10 in 1 CARTON | INJECTION | 10 | | 19 |
| 68083-146-10 | Meropenem | 20 mL in 1 VIAL | INJECTION | 20 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-146 | MEROPENEM INJECTION [GLAND PHARMA LIMITED] | 18 | Current NDC, Legacy NDC, 2 package rows | 20250103_4e4e2c0c-df54-4229-ab90-fa671ecedd57.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-146-10 | 68083014610 | 10 VIAL in 1 CARTON (68083-146-10) / 20 mL in 1 VIAL | 10 vial | 2017-04-28 | 0000-00-00 | No | No | Current |