Prescription drug · ANDA
Mupirocin (Mupirocin calcium) NDC 16714-055
Mupirocin calcium 20 mg/g · Cream · Topical · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-055-01 | 1671400550116714005501 | 1 TUBE in 1 CARTON (16714-055-01) / 15 g in 1 TUBEMarketed from Nov 25, 2020 | |
| 16714-055-02 | 1671400550216714005502 | 1 TUBE in 1 CARTON (16714-055-02) / 30 g in 1 TUBEMarketed from Nov 25, 2020 |
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 calcium
- Active ingredients
- Mupirocin calcium — 20 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- NORTHSTAR RX LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207116
- Marketing start
- Listing expires
- Other FDA classes
- RNA Synthetase Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-055_4f1f71b7-a564-8070-e063-6394a90a52caSPL ID 4f1f71b7-a564-8070-e063-6394a90a52caSPL set ID 6f1c0789-4a3b-473a-96d6-0c479ee32d36RxCUI 311877UNII RG38I2P540UPC 0316714055022
- 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
N416714005501followed by a unit qualifier and the quantityPackage 16714-0055-01. 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)
Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes . ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 16714-055
- What is NDC 16714-055?
- 16714-055 is the product NDC for Mupirocin (mupirocin calcium), Mupirocin calcium 20 mg/g cream, listed with the FDA by NORTHSTAR RX LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mupirocin (Mupirocin calcium).
- What is the active ingredient?
- Mupirocin calcium.
- Who is the labeler?
- NORTHSTAR RX LLC, NDC labeler code 16714. 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 207116
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 |
|---|---|---|---|---|
| Mupirocinmupirocin calcium | Mupirocin calcium 20 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1370 |
| Mupirocinmupirocin calcium | Mupirocin calcium 20 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-3774 |