Metronidazole
- Product NDC
- 0713-0637
- 11-digit product format
- 007130637
- Labeler code
- 0713
- Product ID
- 0713-0637_edf61c59-f083-6b15-e053-2995a90a675b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA078178
- Marketing category
- ANDA
- Marketing start
- 2011-04-01
- Substance
- METRONIDAZOLE
- Active strength
- 7.5 mg/g
- 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 | 7.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 140QMO216E |
| Rxcui | 311679 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0637-37 | Metronidazole | 1 in 1 CARTON | GEL | 1 | | 10 |
| 0713-0637-37 | Metronidazole | 45 g in 1 TUBE | GEL | 45 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Metronidazole | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
| Metronidazole | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
| Carbomer Homopolymer Type C | INACTIVE INGREDIENT | 4Q93RCW27E | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE (METRONIDAZOLE) GEL [G & W LABORATORIES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0637 | METRONIDAZOLE GEL [COSETTE PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20221122_86da8d86-5ab2-f668-fdfd-b0e93e6a2245.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 |
|---|
| 0713-0637-37 | 00713063737 | 1 TUBE in 1 CARTON (0713-0637-37) / 45 g in 1 TUBE | 1 tube | 2011-04-01 | 0000-00-00 | No | No | Current |