Metronidazole
- Product NDC
- 68083-373
- 11-digit product format
- 680830373
- Labeler code
- 68083
- Product ID
- 68083-373_01c8a10a-cb89-4879-a9ff-e2ca4e033c99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA212435
- Marketing category
- ANDA
- Marketing start
- 2020-08-03
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/100mL
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metronidazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METRONIDAZOLE | 500 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311683 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-373-01 | Metronidazole | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 11 |
| 68083-373-01 | Metronidazole | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 11 |
| 68083-373-04 | Metronidazole | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-373 | METRONIDAZOLE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240731_74cf111a-9b83-4f93-b0e8-bc252d471d43.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 |
|---|
| 68083-373-01 | 68083037301 | 100 mL in 1 BAG | 100 ml | | | | | Historical |
| 68083-373-04 | 68083037304 | 4 POUCH in 1 CARTON (68083-373-04) / 1 BAG in 1 POUCH (68083-373-01) / 100 mL in 1 BAG | 4 pouch | 2020-08-03 | 0000-00-00 | No | No | Current |