Miconazole Nitrate
- Product NDC
- 0713-0252
- 11-digit product format
- 007130252
- Labeler code
- 0713
- Product ID
- 0713-0252_21c9ad62-0336-4c7b-ae84-bcb5f7615f85
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA074366
- Marketing category
- ANDA
- Marketing start
- 1996-02-22
- Marketing end
- 0000-00-00
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0713-0252-37 | GM - Gram | 0713-0252 | 4eef55c7-51cd-4f3e-aa0f-27909ec64d7b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998540 | miconazole nitrate 2 % Vaginal Cream | PSN | 0878a5d4-d6c7-4e66-8956-9bd1acd9dfd4 | 1 |
| 998540 | miconazole nitrate 2 % Vaginal Cream | PSN | 6791d4f2-c485-4daf-82c7-0cafa9a7a17d | 1 |
| 998540 | miconazole nitrate 20 MG/ML Vaginal Cream | SCD | 0878a5d4-d6c7-4e66-8956-9bd1acd9dfd4 | 1 |
| 998540 | miconazole nitrate 20 MG/ML Vaginal Cream | SCD | 6791d4f2-c485-4daf-82c7-0cafa9a7a17d | 1 |
| 998540 | miconazole nitrate 2 % Vaginal Cream | SY | 0878a5d4-d6c7-4e66-8956-9bd1acd9dfd4 | 1 |
| 998540 | miconazole nitrate 2 % Vaginal Cream | SY | 6791d4f2-c485-4daf-82c7-0cafa9a7a17d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0713-0252-37 | 00713025237 | 45 g in 1 TUBE, WITH APPLICATOR (0713-0252-37) | 45 g | 1996-02-22 | 0000-00-00 | No | No | Current |