Prescription drug · ANDA
Mupirocin NDC 50268-568
Mupirocin 20 mg/g · Ointment · Topical · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-568-15 | 5026805681550268056815 | 50 TUBE in 1 BOX (50268-568-15) / 50 g in 1 TUBE (50268-568-11)Marketed from Jun 11, 2019 |
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)
- Mupirocin
- Generic name (nonproprietary)
- mupirocin
- Active ingredients
- Mupirocin — 20 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065170
- Marketing start
- Listing expires
- Other FDA classes
- RNA Synthetase Inhibitors (Mechanism)
- Identifiers
- Product ID 50268-568_48d41df2-2bbc-ccd4-e063-6294a90a2c50SPL ID 48d41df2-2bbc-ccd4-e063-6294a90a2c50SPL set ID 8b10c706-ae9c-fc76-e053-2a95a90a4c73RxCUI 106346UNII D0GX863OA5
- Pharmacologic class
- RNA Synthetase Inhibitor Antibacterial
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
N450268056815followed by a unit qualifier and the quantityPackage 50268-0568-15. 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)
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes . ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50268-568
- What is NDC 50268-568?
- 50268-568 is the product NDC for Mupirocin, Mupirocin 20 mg/g ointment, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mupirocin.
- What is the active ingredient?
- Mupirocin.
- Who is the labeler?
- AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mupirocin?
- 42 other product NDCs are listed under this name. See all Mupirocin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mupirocin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mupirocin | Mupirocin calcium 20 mg/g | CreamTopical | Zydus Lifesciences Limited | 70771-1981 | 70771-1981-0170771-1981-02 |
| Mupirocin | Mupirocin calcium 20 mg/g | CreamTopical | Viona Pharmaceuticals Inc | 72578-130 | 72578-0130-0172578-0130-06 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | PAI Holdings, LLC dba PAI Pharma | 0121-1076 | 00121-1076-50 |
| Mupirocinmupirocin ointment | Mupirocin 20 mg/g | OintmentTopical | Kesin Pharma Corporation | 81033-032 | 81033-0032-5081033-0032-99 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-073 | 21922-0073-0421922-0073-0521922-0073-25 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | Redpharm Drug | 67296-2211 | 67296-2211-01 |
| Mupirocin | Mupirocin calcium 20 mg/g | CreamTopical | Alembic Pharmaceuticals Limited | 46708-624 | 46708-0624-1546708-0624-30 |
| mupirocin | Mupirocin 20 mg/g | OintmentTopical | St. Mary's Medical Park Pharmacy | 60760-960 | 60760-0960-22 |
| mupirocin | Mupirocin 20 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-8642 | 68788-8642-02 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-8534 | 68788-8534-02 |
Other NDCs under ANDA 065170
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 |
|---|---|---|---|---|
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | PAI Holdings, LLC dba PAI Pharma | 0121-1076 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-1312 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | Proficient Rx LP | 63187-151 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | NuCare Pharmaceuticals,Inc. | 68071-4321 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | Lohxa | 70166-355 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0254 |
| Mupirocin | Mupirocin 20 mg/g | OintmentTopical | Sportpharm LLC | 85766-207 |