Ivermectin
- Product NDC
- 27854-334
- 11-digit product format
- 278540334
- Labeler code
- 27854
- Product ID
- 27854-334_24b0813f-ac85-aa4d-e063-6394a90a8a19
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ivermectin
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Belmora LLC
- Application
- ANDA210720
- Marketing category
- ANDA
- Marketing start
- 2024-08-12
- Substance
- IVERMECTIN
- Active strength
- 5 mg/g
- Pharmacologic classes
- Antiparasitic [EPC], Pediculicide [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ivermectin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IVERMECTIN | 5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8883YP2R6D |
| Rxcui | 1246673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27854-334-01 | Ivermectin | 1 in 1 CARTON | LOTION | 1 | | 2 |
| 27854-334-01 | Ivermectin | 117 g in 1 TUBE | LOTION | 117 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27854-334 | IVERMECTIN LOTION [BELMORA LLC] | 2 | Current NDC, 2 package rows | 20241019_0d405318-3db5-41b6-a248-a6c1cfe7a765.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 |
|---|
| 27854-334-01 | 27854033401 | 1 TUBE in 1 CARTON (27854-334-01) / 117 g in 1 TUBE | 1 tube | 2024-08-12 | No | No | Historical |