Prescription drug · ANDA
Ivermectin NDC 0591-4052
Ivermectin 10 mg/g · Cream · Topical · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-4052-89 | 00591405289 | 1 TUBE in 1 CARTON (0591-4052-89) / 45 g in 1 TUBEMarketed from Oct 14, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ivermectin
- Generic name (nonproprietary)
- ivermectin
- Active ingredients
- Ivermectin — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210019
- Marketing start
- Listing expires
- Identifiers
- Product ID 0591-4052_14ca838b-d540-4653-ac10-261e77906a51SPL ID 14ca838b-d540-4653-ac10-261e77906a51SPL set ID de9253c3-7d66-47fe-8ad7-8c0d4ee8ebdaRxCUI 1598068UNII 8883YP2R6D
- Pharmacologic class
- Antiparasitic; Pediculicide
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400591405289followed by a unit qualifier and the quantityPackage 00591-4052-89. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210019
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ivermectin | Ivermectin 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8754 |