Over-the-counter drug · OTC MONOGRAPH DRUG
Double Antibiotic (Bacitracin zinc and polymyxin b sulfate) NDC 58980-012
Bacitracin zinc 500 [USP'U]/g; Polymyxin b sulfate 10000 [USP'U]/g · Ointment · Topical · STRATUS PHARMACEUTICALS INC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58980-012Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58980-0012Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58980-012-01 | 58980001201 | 144 PACKET in 1 BOX (58980-012-01) / .9 g in 1 PACKETMarketed from Sep 15, 2017 | |
| 58980-012-05 | 58980001205 | 1 TUBE in 1 BOX (58980-012-05) / 14.2 g in 1 TUBEMarketed from Feb 8, 2021 | |
| 58980-012-10 | 58980001210 | 1 TUBE in 1 BOX (58980-012-10) / 28.35 g in 1 TUBEMarketed from Jan 26, 2026 |
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)
- Double Antibiotic
- Generic name (nonproprietary)
- bacitracin zinc and polymyxin b sulfate
- Active ingredients
- Bacitracin zinc — 500 [USP'U]/gPolymyxin b sulfate — 10000 [USP'U]/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- STRATUS PHARMACEUTICALS INCNDC labeler code 58980
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 004
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Synthesis & Repair (Physiologic effect)Polymyxins (Chemical structure)
- Identifiers
- Product ID 58980-012_6c82f396-e1f6-4210-87b1-2615eedbdc6aSPL ID 6c82f396-e1f6-4210-87b1-2615eedbdc6aSPL set ID f64b3564-ea3c-4316-8f00-f92c08dcad35RxCUI 308512UNII 89Y4M234ES, 19371312D4
- Pharmacologic class
- 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
N458980001201followed by a unit qualifier and the quantityPackage 58980-0012-01. 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 58980-012
- What is NDC 58980-012?
- 58980-012 is the product NDC for Double Antibiotic, Bacitracin zinc 500 [USP'U]/g; Polymyxin b sulfate 10000 [USP'U]/g ointment, listed with the FDA by STRATUS PHARMACEUTICALS INC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Double Antibiotic (BACITRACIN ZINC and POLYMYXIN B SULFATE).
- What is the active ingredient?
- Bacitracin zinc, Polymyxin b sulfate.
- Who is the labeler?
- STRATUS PHARMACEUTICALS INC, NDC labeler code 58980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Double Antibiotic?
- 3 other product NDCs are listed under this name. See all Double Antibiotic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Double Antibiotic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Double Antibioticbacitracin zinc polymyxin b sulfate | Bacitracin zinc 400 [USP'U]/g; Polymyxin b sulfate 5000 [USP'U]/g | OintmentTopical | Encube Ethicals, Inc. | 21922-092 | 21922-0092-05 |
| Double Antibioticbacitracin zinc and polymyxin b sulfate | Bacitracin zinc 500 [USP'U]/g; Polymyxin b sulfate 10000 [USP'U]/g | OintmentTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1212 | 70677-1212-01 |
| Double Antibioticbacitracin zinc and polymyxin b sulfate | Bacitracin zinc 500 [USP'U]/g; Polymyxin b sulfate 10000 [USP'U]/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-2044 | 51672-2044-02 |
Other NDCs under M 004
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 |
|---|---|---|---|---|
| ProCure Bacitracin Zincbacitracin zinc | Bacitracin zinc 500 [iU]/g | OintmentTopical | Twin Med LLC | 55681-016 |
| Ever Ready First Aid Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | EVER READY FIRST AID | 72976-009 |
| Vitacilina First Aid Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 U/g + 2 more ingredients | OintmentTopical | Taisho Pharmaceutical California Inc. | 81929-003 |
| triple antibiotic and pain reliefbacitracin, neomycin, polymyxin b, pramoxine hydrochloride | Bacitracin zinc 500 [USP'U]/g + 3 more ingredients | OintmentTopical | CVS Pharmacy | 69842-562 |
| First Aid Antibiotic and Burn Reliefbacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hydrochloride | Bacitracin zinc 500 [USP'U]/g + 3 more ingredients | OintmentTopical | Amazon.com Services LLC | 72288-824 |
| CareALL Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | New World Imports, Inc | 51824-052 |
| Leader Triple antibioticbacitracin,neomycin,polymxin | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | Cardinal Health 110 dba LEADER | 70000-0687 |
| ER Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | EVER READY FIRST AID | 72976-017 |
| Antibioticbacitracin | Bacitracin 500 [USP'U]/g | OintmentTopical | Topco Associates LLC | 36800-536 |
| Xpect Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | Cintas Corporation | 42961-236 |
| WinCo Maximum Strength Triple Antibioticbacitracin zinc, neomycin sulfate, poymyxin b sulfate, and pramoxine hydrochrloride | Bacitracin zinc 500 [USP'U]/g + 3 more ingredients | OintmentTopical | WinCo Foods, LLC | 67091-272 |
| El Valle Merthiolatebenzalkonium chloride | Benzalkonium chloride 1.3 mg/mL | LiquidTopical | Pharmadel LLC | 55758-375 |
| PS - 2895 Triple Antibiotic , 0.5g | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | Prostat First Aid LLC | 58228-2895 |
| Winco Bacitracin Zincbacitracin zinc | Bacitracin zinc 500 [USP'U]/g | OintmentTopical | WinCo Foods, LLC | 67091-270 |
| Sheffield Triple Antibioticbacitracin zinc, polymyxin b sulfate, neomycin sulfate | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | Sheffield Pharmaceuticals LLC | 11527-162 |
| Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [USP'U]/g + 2 more ingredients | OintmentTopical | Medline Industries, LP | 53329-087 |
| WinCo Original Strength Triple Antibioticbacitracin zinc, neomycin sulfate, and polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | WinCo Foods, LLC | 67091-274 |
| Triple Antibiotic Plus Pain Reliefbacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride | Bacitracin zinc 500 [USP'U]/g + 3 more ingredients | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-2027 |
| First Aid Antibioticbacitracin zinc | Bacitracin zinc 500 [USP'U]/g | OintmentTopical | Medline Industries, LP | 53329-089 |
| Leader Poly Bacitracinfirst aid antibiotic | Bacitracin zinc 500 [USP'U]/g; Polymyxin b sulfate 10000 [USP'U]/g | OintmentTopical | Cardinal Health 110, Inc. | 70000-0093 |
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