Prescription drug · ANDA
Everolimus (Everolimus tablets) NDC 51991-381
Everolimus .75 mg/1 · Tablet · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-381-06 | 5199103810651991038106 | 60 TABLET in 1 BOTTLE (51991-381-06)Marketed from Mar 13, 2023 | |
| 51991-381-60 | 5199103816051991038160 | 60 BLISTER PACK in 1 CARTON (51991-381-60) / 10 TABLET in 1 BLISTER PACK (51991-381-99)Marketed from May 21, 2021 |
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)
- Everolimus
- Generic name (nonproprietary)
- everolimus tablets
- Active ingredients
- Everolimus — .75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205432
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
- Identifiers
- Product ID 51991-381_42ae2051-c48f-49a0-a825-9f116623b2baSPL ID 42ae2051-c48f-49a0-a825-9f116623b2baSPL set ID c7bb6ba1-9a7f-43f5-b058-ef26d4b59221RxCUI 977427, 977434, 977438, 2056895UNII 9HW64Q8G6GUPC 0351991985068, 0351991379997, 0351991985990, 0351991380061, 0351991379065, 0351991380993, 0351991381990, 0351991381068
- Pharmacologic class
- Kinase Inhibitor; mTOR Inhibitor Immunosuppressant
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
N451991038106followed by a unit qualifier and the quantityPackage 51991-0381-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney Transplant : at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1 ) Liver Transplant : Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2 , 5.5 ) Limitations of Use : Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk ( 1.3 ) Recipients of transplanted organs other than kidney or liver ( 1.3 , 5.7 ) Pediatric patients (less than 18 years) ( 1.3 ) 1.1 Prophyl…
Excerpt only. Read the full label for complete information.
About NDC 51991-381
- What is NDC 51991-381?
- 51991-381 is the product NDC for Everolimus (everolimus tablets), Everolimus .75 mg/1 tablet, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Everolimus (Everolimus tablets).
- What is the active ingredient?
- Everolimus.
- Who is the labeler?
- Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Everolimus?
- 65 other product NDCs are listed under this name. See all Everolimus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Everolimus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Everolimus | Everolimus .25 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-003 | 72319-0003-0272319-0003-60 |
| Everolimus | Everolimus .5 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-015 | 72319-0015-0272319-0015-60 |
| Everolimus | Everolimus .75 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-016 | 72319-0016-0272319-0016-60 |
| Everolimus | Everolimus 1 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-017 | 72319-0017-0272319-0017-60 |
| everolimus | Everolimus 7.5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-032 | 82293-0032-1082293-0032-2182293-0032-31 |
| everolimus | Everolimus 2.5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-030 | 82293-0030-1082293-0030-2182293-0030-31 |
| everolimus | Everolimus 5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-031 | 82293-0031-1082293-0031-2182293-0031-31 |
| everolimus | Everolimus 10 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-033 | 82293-0033-1082293-0033-2182293-0033-31 |
| everolimus | Everolimus .75 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-933 | 59651-0933-60 |
| everolimus | Everolimus .25 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-931 | 59651-0931-60 |
Other NDCs under ANDA 205432
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 |
|---|---|---|---|---|
| Everolimuseverolimus tablets | Everolimus .25 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-379 |
| Everolimuseverolimus tablets | Everolimus .5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-380 |
| Everolimus | Everolimus .5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0063 |
| Everolimus | Everolimus .25 mg/1 | TabletOral | Natco Pharma Limited | 63850-0062 |
| Everolimus | Everolimus .75 mg/1 | TabletOral | Natco Pharma Limited | 63850-0064 |
| Everolimus | Everolimus 1 mg/1 | TabletOral | Natco Pharma Limited | 63850-0107 |
| Everolimuseverolimus tablets | Everolimus 1 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-985 |