Over-the-counter drug · OTC MONOGRAPH DRUG

Hydrocortisone (Drs. hydrocortisone) NDC 80489-001

Hydrocortisone 10 mg/g · Cream · Topical · OL PHARMA TECH,LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80489-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80489-0001Add 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
80489-001-0180489000101804890001011 TUBE in 1 CARTON (80489-001-01) / 28.3 g in 1 TUBEMarketed from Jan 1, 2021
80489-001-0280489000102804890001021 TUBE in 1 CARTON (80489-001-02) / 49.5 g in 1 TUBEMarketed from Jan 1, 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)
Hydrocortisone
Generic name (nonproprietary)
drs. hydrocortisone
Active ingredients
Hydrocortisone — 10 mg/g
Dosage form
Cream
Route
Topical
Labeler
OL PHARMA TECH,LLCNDC labeler code 80489
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 016
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 80489-001_48fe7e3f-613b-4f28-e063-6294a90aa4e0SPL ID 48fe7e3f-613b-4f28-e063-6294a90aa4e0SPL set ID b0eac8f3-bb80-6563-e053-2995a90a83c9RxCUI 106258UNII WI4X0X7BPJ
Pharmacologic class
Corticosteroid

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

N480489000101 followed by a unit qualifier and the quantity

Package 80489-0001-01. 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 for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: •eczema •insect bites •poison ivy •poison oak •poison ...

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80489-001

What is NDC 80489-001?
80489-001 is the product NDC for Hydrocortisone (drs. hydrocortisone), Hydrocortisone 10 mg/g cream, 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?
Hydrocortisone (Drs. Hydrocortisone).
What is the active ingredient?
Hydrocortisone.
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 Hydrocortisone?
168 other product NDCs are listed under this name. See all Hydrocortisone 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 Hydrocortisone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
HydrocortisoneHydrocortisone 1 g/100gLotionTopicalAmazon.com Services LLC72288-46972288-0469-25
HydrocortisoneHydrocortisone 5 mg/1TabletOralSolco Healthcare LLC43547-89243547-0892-05
HydrocortisoneHydrocortisone 10 mg/1TabletOralSolco Healthcare LLC43547-89343547-0893-10
HydrocortisoneHydrocortisone 20 mg/1TabletOralSolco Healthcare LLC43547-89443547-0894-10
HydrocortisoneHydrocortisone 1 g/100gCreamTopicalAmazon.com Services LLC72288-71372288-0713-64
HydrocortisoneHydrocortisone 25 mg/gCreamTopicalEncube Ethicals, Inc.21922-06521922-0065-0521922-0065-30
HydrocortisoneHydrocortisone 20 mg/gGelTopicalRedmont Pharmaceuticals, LLC71741-45571741-0455-31
HydrocortisoneHydrocortisone 10 mg/gCreamTopicalSportpharm LLC85766-16685766-0166-1085766-0166-25
hydrocortisoneHydrocortisone 1 g/100gCreamTopicalSportpharm LLC85766-15185766-0151-28
Hydrocortisonehydrocortisone cream 1%Hydrocortisone 1 g/100gCreamTopicalAldermed Inc.87236-00487236-0004-09

All 169 Hydrocortisone NDCs

Other NDCs under M 016

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

FDA NDC Directory listings under M 016
ProductStrengthForm · routeLabelerProduct NDC
2-Pack Facial SerumWater 78.894 g/100mL + 4 more ingredientsLiquidCutaneousGuangzhou Ariel Biotech Co., Ltd.84148-011
2-Pack Facial Serum3-o-ethyl ascorbic acid .5 g/100mL + 3 more ingredientsLiquidCutaneousGuangzhou Ariel Biotech Co., Ltd.84148-012
3M Cavilon Durable BarrierdimethiconeDimethicone 13000 mg/LCreamTopicalSolventum US LLC17518-030
4% 10gTATTOO Numb Cream4% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-031
4% TATTOO Numb Cream4% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-030
456 Acne Relief Creamniacinamide,salicylic acid,centella asiatica root,coptis chinensis rootSalicylic acid 380 mg/50g + 3 more ingredientsCreamTopicalGuangzhou Senmai Biotechnology Co.,Ltd.84509-111
5% Dr.care Numb creamlidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-028
5% MinoxidilMinoxidil 2 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-328
5% MinoxidilMinoxidil 2 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-329
5% MinoxidilBiotin .05 g/100g; Niacinamide 2.5 g/100gSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-335
5% MinoxidilMinoxidil 5 g/100g + 5 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-337
5% Minoxidil for Men and WomenBiotin .05 g/100g; Tocopherol .05 g/100gSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-332
5% Minoxidil Hair GrowthBiotin .1 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-333
5% Minoxidil Hair GrowthMinoxidil 5 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-334
5% Signature Numb creamlidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-026
5% Signature Numb cream5% signatureLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-027
5% Signature Numb cream5% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-029
70% Isopropyl Rubbing Alcoholisopropyl alcoholIsopropyl alcohol 70 mL/100mLLiquidTopicalMY IMPORTS USA LLC51628-4501
911allantoinAllantoin .5 g/100gOintmentTopicalSkinfix, Inc.61328-120
A and DpetrolatumPetrolatum 76 g/100gOintmentTopicalSafetec of America, Inc.61010-4405

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