Ivermectin
- Product NDC
- 0591-4052
- 11-digit product format
- 005914052
- Labeler code
- 0591
- Product ID
- 0591-4052_14ca838b-d540-4653-ac10-261e77906a51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ivermectin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA210019
- Marketing category
- ANDA
- Marketing start
- 2019-10-14
- Substance
- IVERMECTIN
- Active strength
- 10 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 | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8883YP2R6D |
| Rxcui | 1598068 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-4052-89 | Ivermectin | 45 g in 1 TUBE | CREAM | 45 | | 8 |
| 0591-4052-89 | Ivermectin | 1 in 1 CARTON | CREAM | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-4052 | IVERMECTIN CREAM [ACTAVIS PHARMA, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20230112_de9253c3-7d66-47fe-8ad7-8c0d4ee8ebda.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 |
|---|
| 0591-4052-89 | 00591405289 | 1 TUBE in 1 CARTON (0591-4052-89) / 45 g in 1 TUBE | 1 tube | 2019-10-14 | 0000-00-00 | No | No | Current |