Terconazole
- Product NDC
- 0168-0346
- 11-digit product format
- 001680346
- Labeler code
- 0168
- Product ID
- 0168-0346_c54c82fd-d8e5-4943-8727-1432bccac7c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- terconazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- ANDA076712
- Marketing category
- ANDA
- Marketing start
- 2005-02-18
- Substance
- TERCONAZOLE
- Active strength
- 4 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERCONAZOLE | 4 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0KJ2VE664U |
| Rxcui | 313226 |
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 |
|---|
| 0168-0346-46 | Terconazole | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TERCONAZOLE | ACTIVE INGREDIENT | 0KJ2VE664U | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| TERCONAZOLE | ACTIVE MOIETY | 0KJ2VE664U | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | |
| TERCONAZOLE | ACTIVE INGREDIENT | 0KJ2VE664U | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TERCONAZOLE | ACTIVE MOIETY | 0KJ2VE664U | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0346 | TERCONAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20210313_10e84353-93d2-461d-8b79-e9294df047ae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0168-0346-46 | 00168034646 | 45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46) | 45 g | 2005-02-18 | 0000-00-00 | No | No | Current |