Metronidazole
- Product NDC
- 68682-455
- 11-digit product format
- 686820455
- Labeler code
- 68682
- Product ID
- 68682-455_25ae84b0-f8f3-41c3-b5ff-477624171706
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metronidazole
- Dosage form
- GEL
- Route
- VAGINAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA020208
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-04-01
- Marketing end
- 2026-07-31
- Substance
- METRONIDAZOLE
- Active strength
- 7.5 mg/g
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metronidazole
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METRONIDAZOLE | 7.5 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 140QMO216E |
| Rxcui | 142046 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68682-455-70 | Metronidazole | 1 in 1 CARTON | GEL | 1 | 8 | |
| 68682-455-70 | Metronidazole | 70 g in 1 TUBE, WITH APPLICATOR | GEL | 70 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68682-455-70 | GM - Gram | 68682-455 | fef357a2-46d3-4f90-b311-2ebf6e70b1cb | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS] | 1 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS] | 1 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 142046 | metroNIDAZOLE 0.75 % Vaginal Gel | PSN | 8b2c294b-ed70-447c-bbc4-2a8b59f1aca4 | 10 |
| 142046 | metronidazole 0.0075 MG/MG Vaginal Gel | SCD | 8b2c294b-ed70-447c-bbc4-2a8b59f1aca4 | 10 |
| 142046 | metronidazole 0.75 % Vaginal Gel | SY | 8b2c294b-ed70-447c-bbc4-2a8b59f1aca4 | 10 |
| 142046 | metroNIDAZOLE 0.75 % Vaginal Gel | PSN | 526c226a-099b-4eb3-943d-c88b2763b2c1 | 8 |
| 142046 | metronidazole 0.0075 MG/MG Vaginal Gel | SCD | 526c226a-099b-4eb3-943d-c88b2763b2c1 | 8 |
| 142046 | metronidazole 0.75 % Vaginal Gel | SY | 526c226a-099b-4eb3-943d-c88b2763b2c1 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68682-455-70 | 68682045570 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68682-455-70) / 70 g in 1 TUBE, WITH APPLICATOR | 2015-04-01 | 2026-07-31 | No | No | Current |