Terconazole
- Product NDC
- 0168-0347
- 11-digit product format
- 001680347
- Labeler code
- 0168
- Product ID
- 0168-0347_4b5df750-9341-4786-8e10-b0d6950f37ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- terconazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- NDA021735
- Marketing category
- NDA
- Marketing start
- 2005-02-01
- Substance
- TERCONAZOLE
- Active strength
- 8 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
- Brand name suffix
- Vaginal Cream 0.8%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERCONAZOLE | 8 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0KJ2VE664U |
| Rxcui | 313227 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0168-0347-20 | TerconazoleVaginal Cream 0.8% | 20 g in 1 TUBE, WITH APPLICATOR | CREAM | 20 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0347 | TERCONAZOLE VAGINAL CREAM 0.8% (TERCONAZOLE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250328_f59448bd-f730-46d2-a785-c2d6205579ff.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 |
|---|
| 0168-0347-20 | 00168034720 | 20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20) | 20 g | 2020-12-01 | 0000-00-00 | No | No | Current |