Metronidazole
- Product NDC
- 0168-0323
- 11-digit product format
- 001680323
- Labeler code
- 0168
- Product ID
- 0168-0323_111e50c5-83e4-4817-8c3f-ed7416de2dd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Fougera Pharmaceuticals, LLC
- Application
- ANDA076408
- Marketing category
- ANDA
- Marketing start
- 2004-05-28
- Substance
- METRONIDAZOLE
- Active strength
- 7.5 mg/g
- 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 | 7.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311678 |
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 |
|---|
| 0168-0323-46 | Metronidazole | 45 g in 1 TUBE | CREAM | 45 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| metronidazole | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| metronidazole | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| isopropyl palmitate | INACTIVE INGREDIENT | 8CRQ2TH63M | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| lactic acid | INACTIVE INGREDIENT | 33X04XA5AT | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0323 | METRONIDAZOLE CREAM [FOUGERA PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20220701_43ed872b-63ac-4a22-9c9e-cc0e05bcc41e.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 |
|---|
| 0168-0323-46 | 00168032346 | 45 g in 1 TUBE (0168-0323-46) | 45 g | 2004-05-28 | 0000-00-00 | No | No | Current |