Metronidazole
- Product NDC
- 46708-021
- 11-digit product format
- 467080021
- Labeler code
- 46708
- Product ID
- 46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA090222
- Marketing category
- ANDA
- Marketing start
- 2010-05-07
- Substance
- METRONIDAZOLE
- Active strength
- 750 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 | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 636559 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-021-30 | 2023-02-01 | C162847 | 48780-1 | f386c64a-1261-0266-e053-dadaa90a7c1a | Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-021-31 | 2023-02-01 | C162847 | 48780-1 | f386c64a-1261-0266-e053-dadaa90a7c1a | Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-021-50 | 2023-02-01 | C162847 | 48780-1 | f386c64a-1261-0266-e053-dadaa90a7c1a | Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-021-71 | 2023-02-01 | C162847 | 48780-1 | f386c64a-1261-0266-e053-dadaa90a7c1a | Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-021-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1261-0266-e053-dadaa90a7c1a | Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-021-31 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1261-0266-e053-dadaa90a7c1a | Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-021-50 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1261-0266-e053-dadaa90a7c1a | Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-021-71 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1261-0266-e053-dadaa90a7c1a | Metronidazole Extended-Release Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets, and other antibacterial drugs, metronidazole extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-021-30 | Metronidazole | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 13 |
| 46708-021-31 | Metronidazole | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 13 |
| 46708-021-50 | Metronidazole | 50 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 50 | | 13 |
| 46708-021-71 | Metronidazole | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-021 | METRONIDAZOLE TABLET, FILM COATED, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 13 | Current NDC, Legacy NDC, 4 package rows | 20230202_80c79325-1ea4-46f8-b9b8-967b7640c51d.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 |
|---|
| 46708-021-30 | 46708002130 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-30) | 2010-05-07 | 0000-00-00 | No | No | Current |
| 46708-021-31 | 46708002131 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-31) | 2010-05-07 | 0000-00-00 | No | No | Current |
| 46708-021-50 | 46708002150 | 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-50) | 2010-05-07 | 0000-00-00 | No | No | Current |
| 46708-021-71 | 46708002171 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-71) | 2010-05-07 | 0000-00-00 | No | No | Current |