METRONIDAZOLE
- Product NDC
- 0404-9991
- 11-digit product format
- 004049991
- Labeler code
- 0404
- Product ID
- 0404-9991_1f13748c-910c-4ec8-8669-ecf7507f8320
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metronidazole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA206191
- Marketing category
- ANDA
- Marketing start
- 2023-02-24
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/100mL
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METRONIDAZOLE
- Listing expiration
- 2026-12-31
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 |
|---|
| 0404-9991-00 | METRONIDAZOLE | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 4 |
| 0404-9991-00 | METRONIDAZOLE | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9991 | METRONIDAZOLE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 3 | Current NDC, 2 package rows | 20240327_df7df946-c83f-4adf-9007-aff4f757a665.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9991-00 | 00404999100 | 1 BAG in 1 BAG (0404-9991-00) / 100 mL in 1 BAG | 1 bag | 2023-02-24 | No | No | Historical |