Prescription drug · ANDA
Ivermectin NDC 42799-806
Ivermectin 3 mg/1 · Tablet · Oral · Edenbridge Pharmaceuticals LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42799-806-01 | 4279908060142799080601 | 2 BLISTER PACK in 1 CARTON (42799-806-01) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 15, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204154
- Marketing start
- Listing expires
- Identifiers
- Product ID 42799-806_46410c0e-07e7-7194-e063-6394a90a3997SPL ID 46410c0e-07e7-7194-e063-6394a90a3997SPL set ID 847a1dd7-d65b-4a0e-a67d-d90392059dacRxCUI 311207UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442799080601followed by a unit qualifier and the quantityPackage 42799-0806-01. 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)
INDICATIONS AND USAGE Ivermectin is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis . This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin (See CLINICAL PHARMACOLOGY, Clinical Studies ). Onchocerciasis Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus . This indication is based on randomized, double-blin…
Excerpt only. Read the full label for complete information.
About NDC 42799-806
- What is NDC 42799-806?
- 42799-806 is the product NDC for Ivermectin, Ivermectin 3 mg/1 tablet, listed with the FDA by Edenbridge Pharmaceuticals LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ivermectin.
- What is the active ingredient?
- Ivermectin.
- Who is the labeler?
- Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ivermectin?
- 28 other product NDCs are listed under this name. See all Ivermectin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ivermectin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ivermectin | Ivermectin 5 mg/g | LotionTopical | Azurity Pharmaceuticals, Inc. | 24338-119 | 24338-0119-45 |
| Ivermectin | Ivermectin 5 mg/g | LotionTopical | YYBA Corp | 73581-021 | 73581-0021-04 |
| Ivermectin | Ivermectin 3 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-293 | 27241-0293-73 |
| Ivermectin | Ivermectin 5 mg/g | LotionTopical | AmerisourceBergen | 46122-827 | 46122-0827-36 |
| Ivermectin | Ivermectin 3 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1731 | 70771-1731-03 |
| Ivermectin | Ivermectin 3 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-223 | 72578-0223-83 |
| Ivermectin | Ivermectin 5 mg/g | LotionTopical | CVS Pharmacy | 51316-985 | 51316-0985-08 |
| Ivermectin | Ivermectin 3 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-206 | 72888-0206-0972888-0206-3072888-0206-66 |
| Ivermectin | Ivermectin 6 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-207 | 72888-0207-0972888-0207-3072888-0207-66 |
| ivermectin | Ivermectin 3 mg/1 | TabletOral | EPIC PHARMA LLC | 42806-017 | 42806-0017-20 |
Other NDCs under ANDA 204154
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 3 mg/1 | TabletOral | A-S Medication Solutions | 50090-5587 |
| Ivermectin | Ivermectin 3 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2242 |
| Ivermectin | Ivermectin 3 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-619 |