Metronidazole
- Product NDC
- 42254-069
- 11-digit product format
- 422540069
- Labeler code
- 42254
- Product ID
- 42254-069_ae578c2d-7ea2-4e18-bad8-c1da2429b7cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metronidazole
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA077547
- Marketing category
- ANDA
- Marketing start
- 2006-07-13
- Marketing end
- 0000-00-00
- Substance
- METRONIDAZOLE
- Active strength
- 8 mg/g
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55 | Product name | 5 | 20251024 |
| 7f6d14e0-4366-41bc-a4a9-b74c79a20e17 | Product name | 1 | 20250623 |
| e6d321b0-0e5e-7da6-f043-92b6a91f00a1 | Product name | 5 | 20250515 |
| e1aac33b-94ae-4ee9-905b-299f7263853b | Product name | 3 | 20250124 |
| 16642716-d28a-4f90-8dcb-3921cd8c8109 | Product name | 4 | 20240516 |
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| a5070875-62bb-61e1-fd46-8f7054197a40 | Product name | 8 | 20180215 |
| 0add4de9-d152-3375-3390-1123dddc5e3d | Product name | 1 | 20140508 |
| 33ca0fcc-1011-92dc-50a9-a383683eed1e | Product name | 1 | 20140508 |
| 53f39d9f-cd3f-04e1-c668-d4580719d57d | Product name | 1 | 20140508 |
| a804000f-b74f-0b5d-d17b-aa767c286ddb | Product name | 1 | 20140508 |
| a91ea265-6e02-c08f-93c8-686d54180529 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-069-45 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d0d-c013-e053-90daa90a1393 | Metronidazole Topical Gel USP, 0.75% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-069-45 | Metronidazole | 45 g in 1 TUBE | GEL | 45 | 1 | |
| 42254-069-45 | Metronidazole | 1 in 1 CARTON | GEL | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-069-45 | GM - Gram | 42254-069 | dd4e116f-405c-4902-aea5-52785b3c7843 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE GEL [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311679 | metroNIDAZOLE 0.75 % Topical Gel | PSN | ae578c2d-7ea2-4e18-bad8-c1da2429b7cb | 1 |
| 311679 | metronidazole 0.0075 MG/MG Topical Gel | SCD | ae578c2d-7ea2-4e18-bad8-c1da2429b7cb | 1 |
| 311679 | metronidazole 0.75 % Topical Gel | SY | ae578c2d-7ea2-4e18-bad8-c1da2429b7cb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 42254-069-45 | 42254006945 | 45 g in 1 TUBE | 45 g | Historical |