TERCONAZOLE
- Product NDC
- 21695-933
- 11-digit product format
- 216950933
- Labeler code
- 21695
- Product ID
- 21695-933_472e7b07-83fc-4857-9cc0-50e6aa03f10d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- terconazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA019964
- Marketing category
- NDA
- Marketing start
- 2004-04-01
- Marketing end
- 0000-00-00
- Substance
- TERCONAZOLE
- Active strength
- 8 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [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 |
|---|---|---|---|
| a1f2acc3-46a1-8c88-4468-5826c2e9fea6 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-933-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-484b-48b1-e053-8cdaa90a720a | TERCONAZOLE VAGINAL CREAM 0.8% 3-Day Regimen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-933-20 | TERCONAZOLE | 20 g in 1 TUBE, WITH APPLICATOR | CREAM | 20 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-933-20 | GM - Gram | 21695-933 | b55675b0-124a-44fd-b4e0-a4a6ec3e9501 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TERCONAZOLE | ACTIVE INGREDIENT | 0KJ2VE664U | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| TERCONAZOLE | ACTIVE MOIETY | 0KJ2VE664U | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313227 | terconazole 0.8 % Vaginal Cream | PSN | 472e7b07-83fc-4857-9cc0-50e6aa03f10d | 1 |
| 313227 | terconazole 8 MG/ML Vaginal Cream | SCD | 472e7b07-83fc-4857-9cc0-50e6aa03f10d | 1 |
| 313227 | terconazole 0.8 % Vaginal Cream | SY | 472e7b07-83fc-4857-9cc0-50e6aa03f10d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-933-20 | 21695093320 | 20 g in 1 TUBE, WITH APPLICATOR | 20 g | Historical |