Terconazole
- Product NDC
- 53002-8130
- 11-digit product format
- 530028130
- Labeler code
- 53002
- Product ID
- 53002-8130_2d3f4a33-71aa-43e0-b0c9-54e6f513f27f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terconazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- RPK Pharmaceuticals, Inc.
- 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
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53002-8130-1 | Terconazole | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | | 5 |
| 53002-8130-1 | Terconazole | 1 in 1 CARTON | CREAM | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-8130 | TERCONAZOLE CREAM [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_77271d50-de82-4345-a003-e383e8e6576b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-8130-1 | 53002813001 | 1 TUBE, WITH APPLICATOR in 1 CARTON (53002-8130-1) > 45 g in 1 TUBE, WITH APPLICATOR | 2018-10-01 | 0000-00-00 | No | No | Current |