Prescription drug · ANDA
Posaconazole NDC 0527-2133
Posaconazole 100 mg/1 · Tablet, Delayed release · Oral · Lannett Company Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-2133-30 | 0052721333000527213330 | 24 TABLET, DELAYED RELEASE in 1 CARTON (0527-2133-30)Marketed from Jan 31, 2021 | |
| 0527-2133-35 | 0052721333500527213335 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-35)Marketed from Aug 28, 2019 | |
| 0527-2133-43 | 0052721334300527213343 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-43)Marketed from Aug 28, 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)
- Posaconazole
- Generic name (nonproprietary)
- posaconazole
- Active ingredients
- Posaconazole — 100 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Lannett Company Inc.NDC labeler code 0527
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212411
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0527-2133_291b0655-036f-4073-a475-c33a411db178SPL ID 291b0655-036f-4073-a475-c33a411db178SPL set ID 94a9b028-a2bc-4f41-884d-2d6c536881fcRxCUI 1482908UNII 6TK1G07BHZUPC 0305272133358
- Pharmacologic class
- Azole Antifungal
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
N400527213330followed by a unit qualifier and the quantityPackage 00527-2133-30. 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)
Posaconazole delayed-release tablets is an azole antifungal indicated as follows: Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) o Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaco…
Excerpt only. Read the full label for complete information.
About NDC 0527-2133
- What is NDC 0527-2133?
- 0527-2133 is the product NDC for Posaconazole, Posaconazole 100 mg/1 tablet, delayed release, listed with the FDA by Lannett Company Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Posaconazole.
- What is the active ingredient?
- Posaconazole.
- Who is the labeler?
- Lannett Company Inc., NDC labeler code 0527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Posaconazole?
- 32 other product NDCs are listed under this name. See all Posaconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Posaconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| posaconazole | Posaconazole 100 mg/1 | Tablet, CoatedOral | Novadoz Pharmaceuticals LLC | 72205-168 | 72205-0168-60 |
| Posaconazole | Posaconazole 18 mg/mL | SolutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-370 | 31722-0370-31 |
| Posaconazole | Posaconazole 100 mg/1 | Tablet, Delayed releaseOral | Aurobindo Pharma Limited | 59651-596 | 59651-0596-60 |
| posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-911 | 68462-0911-01 |
| Posaconazole | Posaconazole 100 mg/1 | Tablet, Delayed releaseOral | A2A Integrated Pharmaceuticals | 73141-023 | 73141-0023-02 |
| posaconazole | Posaconazole 18 mg/mL | SolutionIntravenous | Mylan Institutional LLC | 67457-665 | 67457-0665-20 |
| posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-904 | 68462-0904-01 |
| Posaconazole | Posaconazole 18 mg/mL | InjectionIntravenous | Eugia US LLC | 55150-388 | 55150-0388-01 |
| Posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | Fresensius Kabi USA, LLC | 63323-685 | 63323-0685-17 |
| posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-577 | 68083-0577-01 |
Other NDCs under ANDA 212411
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 |
|---|---|---|---|---|
| Posaconazole | Posaconazole 100 mg/1 | Tablet, Delayed releaseOral | ATLANTIC BIOLOGICALS CORP. | 17856-2133 |
| Posaconazole | Posaconazole 100 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-523 |
| Posaconazoleposaconazole delayed-release | Posaconazole 100 mg/1 | TabletOral | Chartwell RX, LLC | 62135-429 |