Metronidazole
- Product NDC
- 42546-700
- 11-digit product format
- 425460700
- Labeler code
- 42546
- Product ID
- 42546-700_e8f3ea4a-435c-4869-9fb0-4ac62cbbd049
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Prugen, Inc.
- Application
- ANDA077819
- Marketing category
- ANDA
- Marketing start
- 2006-07-18
- Marketing end
- 0000-00-00
- Substance
- METRONIDAZOLE
- Active strength
- 8 mg/g
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 42546-700-45 | Metronidazole | 1 in 1 CARTON | GEL | 1 | | 1 |
| 42546-700-45 | Metronidazole | 45 g in 1 TUBE | GEL | 45 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Metronidazole | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
| Metronidazole | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42546-700 | METRONIDAZOLE GEL [PRUGEN, INC.] | 1 | Legacy NDC, 2 package rows | 20150731_8fbbbd41-dfeb-4e02-9a50-653a2c2c03d4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 42546-700-45 | 42546070045 | 1 in 1 CARTON | Historical |