Metronidazole
- Product NDC
- 68071-1876
- 11-digit product format
- 680711876
- Labeler code
- 68071
- Product ID
- 68071-1876_465660cf-2b4e-f757-e063-6294a90af71e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA203458
- Marketing category
- ANDA
- Marketing start
- 2014-06-01
- Substance
- METRONIDAZOLE
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311681 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1876-0 | Metronidazole | 42 in 1 BOTTLE | TABLET, FILM COATED | 42 | | 8 |
| 68071-1876-1 | Metronidazole | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 8 |
| 68071-1876-2 | Metronidazole | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 8 |
| 68071-1876-3 | Metronidazole | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 68071-1876-4 | Metronidazole | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 8 |
| 68071-1876-5 | Metronidazole | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 8 |
| 68071-1876-8 | Metronidazole | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1876 | METRONIDAZOLE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 7 package rows | 20250104_4040db14-750f-6d20-e054-00144ff8d46c.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 |
|---|
| 68071-1876-0 | 68071187600 | 42 TABLET, FILM COATED in 1 BOTTLE (68071-1876-0) | 2025-12-19 | | No | No | Current |
| 68071-1876-1 | 68071187601 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-1876-1) | 2014-06-01 | 0000-00-00 | No | No | Current |
| 68071-1876-2 | 68071187602 | 21 TABLET, FILM COATED in 1 BOTTLE (68071-1876-2) | 2014-06-01 | 0000-00-00 | No | No | Current |
| 68071-1876-3 | 68071187603 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-1876-3) | 2014-06-01 | 0000-00-00 | No | No | Current |
| 68071-1876-4 | 68071187604 | 14 TABLET, FILM COATED in 1 BOTTLE (68071-1876-4) | 2014-06-01 | 0000-00-00 | No | No | Current |
| 68071-1876-5 | 68071187605 | 40 TABLET, FILM COATED in 1 BOTTLE (68071-1876-5) | 2014-06-01 | 0000-00-00 | No | No | Current |
| 68071-1876-8 | 68071187608 | 28 TABLET, FILM COATED in 1 BOTTLE (68071-1876-8) | 2014-06-01 | 0000-00-00 | No | No | Current |