Metronidazole
- Product NDC
- 62135-795
- 11-digit product format
- 621350795
- Labeler code
- 62135
- Product ID
- 62135-795_462a5456-eaf5-6f97-e063-6294a90ad050
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA205245
- Marketing category
- ANDA
- Marketing start
- 2017-11-29
- Substance
- METRONIDAZOLE
- Active strength
- 250 mg/1
- 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311681, 314106 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-795-90 | Metronidazole | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-795 | METRONIDAZOLE TABLET [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241025_40509b3c-b725-400c-abe5-d6d5714d405d.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 |
|---|
| 62135-795-90 | 62135079590 | 90 TABLET in 1 BOTTLE (62135-795-90) | 90 tablet | 2023-11-07 | No | No | Current |