Terconazole
- Product NDC
- 21695-844
- 11-digit product format
- 216950844
- Labeler code
- 21695
- Product ID
- 21695-844_5527cd23-567b-4019-8e5c-f71ee7ed2689
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terconazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076043
- Marketing category
- ANDA
- Marketing start
- 2005-01-19
- Marketing end
- 0000-00-00
- Substance
- TERCONAZOLE
- Active strength
- 4 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 |
|---|---|---|---|---|---|
| 21695-844-45 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4a40-48b1-e053-8cdaa90a720a | TERCONAZOLE VAGINAL CREAM 0.4% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-844-45 | Terconazole | 45 g in 1 TUBE | CREAM | 45 | 1 | |
| 21695-844-45 | Terconazole | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-844-45 | GM - Gram | 21695-844 | 286ccb1d-7e95-4e44-96d5-59fd3a97905d | 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 |
|---|---|---|---|---|
| 313226 | terconazole 0.4 % Vaginal Cream | PSN | 5527cd23-567b-4019-8e5c-f71ee7ed2689 | 1 |
| 313226 | terconazole 4 MG/ML Vaginal Cream | SCD | 5527cd23-567b-4019-8e5c-f71ee7ed2689 | 1 |
| 313226 | terconazole 0.4 % Vaginal Cream | SY | 5527cd23-567b-4019-8e5c-f71ee7ed2689 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-844-45 | 21695084445 | 45 g in 1 TUBE | 45 g | Historical |