Over-the-counter drug · OTC MONOGRAPH DRUG
Drs. pharmacy triple antibiotic NDC 80489-012
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment · Neomycin sulfate 3.5 mg/g + 2 more ingredients · Ointment · Topical · OL PHARMA TECH, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80489-012-01 | 8048900120180489001201 | 1 TUBE in 1 CARTON (80489-012-01) / 14 g in 1 TUBEMarketed from Feb 16, 2021 | |
| 80489-012-02 | 8048900120280489001202 | 1 TUBE in 1 CARTON (80489-012-02) / 28.3 g in 1 TUBEMarketed from Feb 16, 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)
- Drs. pharmacy triple antibiotic
- Generic name (nonproprietary)
- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
- Active ingredients
- Neomycin sulfate — 3.5 mg/gBacitracin zinc — 400 [USP'U]/gPolymyxin b sulfate — 5000 [USP'U]/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- OL PHARMA TECH, LLCNDC labeler code 80489
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 003
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Decreased Cell Wall Synthesis & Repair (Physiologic effect)Polymyxins (Chemical structure)
- Identifiers
- Product ID 80489-012_2b51ff20-db0e-8b5d-e063-6294a90a88d0SPL ID 2b51ff20-db0e-8b5d-e063-6294a90a88d0SPL set ID bb730976-0045-c0ae-e053-2a95a90af34eRxCUI 204602UNII 057Y626693, 89Y4M234ES, 19371312D4
- Pharmacologic class
- Aminoglycoside Antibacterial; Polymyxin-class 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
N480489001201followed by a unit qualifier and the quantityPackage 80489-0012-01. 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)
Uses First aid to help prevent infection in minor: cuts scrapes burns
Excerpt only. Read the full label for complete information.
About NDC 80489-012
- What is NDC 80489-012?
- 80489-012 is the product NDC for Drs. pharmacy triple antibiotic, Neomycin sulfate 3.5 mg/g + 2 more ingredients ointment, listed with the FDA by OL PHARMA TECH, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Drs. pharmacy triple antibiotic (Bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment).
- What is the active ingredient?
- Neomycin sulfate, Bacitracin zinc, Polymyxin b sulfate.
- Who is the labeler?
- OL PHARMA TECH, LLC, NDC labeler code 80489. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Drs. pharmacy triple antibiotic?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 003
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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