Metronidazole
- Product NDC
- 0713-0633
- 11-digit product format
- 007130633
- Labeler code
- 0713
- Product ID
- 0713-0633_0b47088a-fa40-b41e-e063-6394a90acfb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA077549
- Marketing category
- ANDA
- Marketing start
- 2008-03-13
- 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 | 311678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0633-37 | Metronidazole | 45 g in 1 TUBE | CREAM | 45 | | 8 |
| 0713-0633-37 | Metronidazole | 1 in 1 CARTON | CREAM | 1 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Metronidazole | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
| Metronidazole | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
| Isopropyl Palmitate | INACTIVE INGREDIENT | 8CRQ2TH63M | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
| Lactic Acid | INACTIVE INGREDIENT | 33X04XA5AT | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0633 | METRONIDAZOLE CREAM [COSETTE PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20231130_de4cb39f-cc6e-98fb-05e5-103f3aca2dad.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 |
|---|
| 0713-0633-37 | 00713063337 | 1 TUBE in 1 CARTON (0713-0633-37) / 45 g in 1 TUBE | 1 tube | 2008-03-13 | 0000-00-00 | No | No | Current |