CLOTRIMAZOLE
- Product NDC
- 16571-686
- 11-digit product format
- 165710686
- Labeler code
- 16571
- Product ID
- 16571-686_de2c09da-6280-4873-859a-80e779643612
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLOTRIMAZOLE
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA215641
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CLOTRIMAZOLE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOTRIMAZOLE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G07GZ97H65 |
| Rxcui | 309371 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-686-07 | CLOTRIMAZOLE | 70 in 1 BOTTLE | LOZENGE | 70 | | 2 |
| 16571-686-14 | CLOTRIMAZOLE | 140 in 1 BOTTLE | LOZENGE | 140 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-686 | CLOTRIMAZOLE LOZENGE [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 2 package rows | 20240501_980736aa-751a-4642-ab85-a309435fd02f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-686-07 | 16571068607 | 70 LOZENGE in 1 BOTTLE (16571-686-07) | 70 lozenge | 2024-05-01 | No | No | Historical |
| 16571-686-14 | 16571068614 | 140 LOZENGE in 1 BOTTLE (16571-686-14) | 140 lozenge | 2024-05-01 | No | No | Historical |