Over-the-counter drug · OTC MONOGRAPH DRUG

Bacitracin Zinc NDC 58980-011

Bacitracin zinc 500 [USP'U]/g · Ointment · Topical · STRATUS PHARMACEUTICALS INC

NDC codes

FDA NDC Directory
Product NDC (as listed)58980-011Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58980-0011Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
58980-011-0158980001101144 PACKET in 1 BOX (58980-011-01) / 1 g in 1 PACKETMarketed from May 15, 2020
58980-011-10589800011101 TUBE in 1 BOX (58980-011-10) / 28.35 g in 1 TUBEMarketed from Sep 15, 2017

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)
Bacitracin Zinc
Generic name (nonproprietary)
bacitracin zinc
Active ingredients
Bacitracin zinc — 500 [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 005
Marketing start
Listing expires
Other FDA classes
Decreased Cell Wall Synthesis & Repair (Physiologic effect)
Identifiers
Product ID 58980-011_989398c9-b804-46c7-b8bf-20d9dabcb245SPL ID 989398c9-b804-46c7-b8bf-20d9dabcb245SPL set ID b2cb3a96-b0ca-42ee-8056-91d5450fb376RxCUI 1366116UNII 89Y4M234ES

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

N458980001101 followed by a unit qualifier and the quantity

Package 58980-0011-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 58980-011

What is NDC 58980-011?
58980-011 is the product NDC for Bacitracin Zinc, Bacitracin zinc 500 [USP'U]/g ointment, listed with the FDA by STRATUS PHARMACEUTICALS INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Bacitracin Zinc.
What is the active ingredient?
Bacitracin zinc.
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 Bacitracin Zinc?
16 other product NDCs are listed under this name. See all Bacitracin Zinc NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bacitracin Zinc NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bacitracin Zincfirst aid antibioticBacitracin zinc 500 [USP'U]/gOintmentTopicalAldermed Inc.87236-00187236-0001-0187236-0001-0987236-0001-14+2 more
Bacitracin ZincBacitracin zinc 500 [USP'U]/gOintmentTopicalTrifecta Pharmaceuticals USA LLC69396-16369396-0163-09
Bacitracin Zincfirst aid antibioticBacitracin zinc 500 [USP'U]/gOintmentTopicalEncube Ethicals, Inc.21922-09121922-0091-0421922-0091-05
Bacitracin ZincBacitracin zinc 500 [USP'U]/gOintmentTopicalChain Drug Marketing Association Inc.83324-04083324-0040-01
Bacitracin ZincBacitracin zinc 500 [USP'U]/gOintmentTopicalSTRATEGIC SOURCING SERVICES LLC70677-121170677-1211-01
Bacitracin ZincBacitracin zinc 500 [iU]/gOintmentTopicalHenry Schein0404-017200404-0172-50
Bacitracin ZincBacitracin zinc 500 [iU]/gOintmentTopicalHenry Schein0404-017000404-0170-50
Bacitracin ZincBacitracin zinc 500 [USP'U]/gOintmentTopicalGeri-Care Pharmaceuticals, Corp.57896-14557896-0145-14
Bacitracin ZincBacitracin zinc 500 [USP'U]/gOintmentTopicalTrifecta Pharmaceuticals USA LLC69396-09869396-0098-09
Bacitracin Zincfirst aid antibioticBacitracin zinc 500 [USP'U]/gOintmentTopicalBluePoint Laboratories68001-53168001-0531-4568001-0531-46

All 17 Bacitracin Zinc NDCs

Other NDCs under M 005

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 005
ProductStrengthForm · routeLabelerProduct NDC
Miconazole NitrateMiconazole nitrate 20 mg/gCreamTopicalA-S Medication Solutions50090-1071
Tagrid Eczema Cream Colloidal Oatmeal 1%colloidal oatmealOatmeal 1 g/100gCreamTopicalTAGRID LLC85384-0024
SSPROTIP X Extra Strength Nail Renewal PatchestolnaftateTolnaftate .01 g/1PatchTopicalGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD85966-016
Tolnafatetolnaftate powder sprayTolnaftate 1.3 g/130gAerosol, SprayTopicalCVS Pharmacy69842-512
Tagrid Antifungal Jock Itch Cream Non-Steroidal Clotrimazole 1%clotrimazoleClotrimazole 1 g/100gCreamTopicalTAGRID LLC85384-0021
Saviland PRO Extra Strength Toenail Renewal PatchestolnaftateTolnaftate .01 g/1PatchTopicalGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD85966-014
SERYNTH Multi-Purpose Nail Solutiontolnaftate 1% multi-purpose nail solutionTolnaftate 1 g/100mLCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-100
Tagrid Intertrigo Cream For Skin Fold Rash Clotrimazole 1%clotrimazoleClotrimazole 1 g/100gCreamTopicalTAGRID LLC85384-0022
Saviland SSPro X Series Extra Strength Toenail Renewal PatchestolnaftateTolnaftate .01 g/1PatchTopicalGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD85966-015
Silka Athletes Footmiconazole nitrateMiconazole nitrate 20 mg/gAerosol, SprayTopicalGenomma Lab USA50066-084
Medlinemiconazole nitrateMiconazole nitrate 20 mg/100gCreamTopicalMedline Industries, LP53329-218
SERYNTH Clotrimazoleclotrimazole1% clotrimazoleClotrimazole 1 g/100gCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-101
Tagrid Feminine Itch Relief Cream Antifungal Formula Clotrimazole 1%clotrimazoleClotrimazole 1 g/100gCreamTopicalTAGRID LLC85384-0023
Hand Sanitizer Lemon ScentedalcoholAlcohol 62 mL/100mLGelTopicalTaizhou Juheng Biotechnology Co., Ltd.87614-002
Tolnafatetolnaftate powder sprayTolnaftate 1.3 g/130gAerosol, SprayTopicalChain Drug Consortium, LLC68016-663
KetoconClear CreamketoconazoleKetoconazole 1 g/100gCreamTopicalGuangzhou Shunfei Network Technology Co., Ltd.87976-002
sunmark antifungaltolnaftateTolnaftate 10 mg/gCreamTopicalA-S Medication Solutions50090-3358
Toenail Fungus Treatment Extra Strength Pentolnaftate, undecylenic acidTolnaftate 1 g/100mL; Undecylenic acid 25 g/100mLLiquidTopicalLianjiang Shanlilai E-commerce Co., Ltd.85038-001
MICONAZOLE Nitrate 2% Cream ANTIFUNGALmiconazole nitrateMiconazole nitrate 2 g/100gCreamTopicalPreferred Pharmaceuticals Inc.68788-8845
TOENAIL FUNGUS TREATMENT Liquidtolnaftate, undecylenic acidUndecylenic acid 25 g/100mL; Tolnaftate 1 g/100mLLiquidTopicalLianjiang Shanlilai E-commerce Co., Ltd.85038-002

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