Metronidazole
- Product NDC
- 0168-0383
- 11-digit product format
- 001680383
- Labeler code
- 0168
- Product ID
- 0168-0383_76e5eaff-57c7-4120-af16-c7e8cbac8688
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Fougera Pharmaceuticals, LLC
- Application
- ANDA077197
- Marketing category
- ANDA
- Marketing start
- 2006-05-24
- Substance
- METRONIDAZOLE
- Active strength
- 7.5 mg/mL
- 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/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 242736 |
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 |
|---|
| 0168-0383-60 | Metronidazole | 59 mL in 1 BOTTLE, PLASTIC | LOTION | 59 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | F68VH75CJC | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| STEARETH-21 | INACTIVE INGREDIENT | 53J3F32P58 | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYOXYL 100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE LOTION [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0383 | METRONIDAZOLE LOTION [FOUGERA PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20220708_5368755a-dd37-4e34-843f-ece6bac8ef6a.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 |
|---|
| 0168-0383-60 | 00168038360 | 59 mL in 1 BOTTLE, PLASTIC (0168-0383-60) | 59 ml | 2006-05-24 | 0000-00-00 | No | No | Current |