Over-the-counter drug · OTC MONOGRAPH DRUG

Hydrocortisone (Hydrocortisone 1%) NDC 11383-268

Hydrocortisone 1 g/100g · Ointment · Topical · Weeks & Leo Co., Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)11383-268Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11383-0268Add 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
11383-268-011138302680128 g in 1 TUBE (11383-268-01)Marketed from Oct 1, 2023
11383-268-021138302680259 g in 1 TUBE (11383-268-02)Marketed from Oct 1, 2023

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)
hydrocortisone 1%
Active ingredients
Hydrocortisone — 1 g/100g
Dosage form
Ointment
Route
Topical
Labeler
Weeks & Leo Co., Inc.NDC labeler code 11383
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 017
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 11383-268_0c5325e3-4797-856c-e063-6394a90a1f90SPL ID 0c5325e3-4797-856c-e063-6394a90a1f90SPL set ID 0c5325e3-4796-856c-e063-6394a90a1f90RxCUI 203105UNII 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

N411383026801 followed by a unit qualifier and the quantity

Package 11383-0268-01. 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 seborrheic dermatitis poison ivy, poison oak, and poison sumac psoriasis insect bites cosmetics jewelry detergents soaps temporarily relieves external anal and genital itching other uses of this product should be only under the advise and supervision of a doctor

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11383-268

What is NDC 11383-268?
11383-268 is the product NDC for Hydrocortisone (hydrocortisone 1%), Hydrocortisone 1 g/100g ointment, listed with the FDA by Weeks & Leo Co., Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocortisone (Hydrocortisone 1%).
What is the active ingredient?
Hydrocortisone.
Who is the labeler?
Weeks & Leo Co., Inc., NDC labeler code 11383. 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?
169 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 10 mg/1TabletOralSolco Healthcare LLC43547-89343547-0893-10
HydrocortisoneHydrocortisone 5 mg/1TabletOralSolco Healthcare LLC43547-89243547-0892-05
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 170 Hydrocortisone NDCs

Other NDCs under M 017

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

FDA NDC Directory listings under M 017
ProductStrengthForm · routeLabelerProduct NDC
Pain No More Therapymenthol camphorMenthol .03 g/g; Camphor (Synthetic) .03 g/gGelTopicalSOMBRA COSMETICS INC.61577-7365
Diphenhydramine Hydrochloride and Zinc AcetateDiphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/gCreamTopicalSTRATEGIC SOURCING SERVICES LLC70677-1213
MyDerm Aloe and LidocainelidocaineLidocaine hydrochloride .5 g/100mLGelTopicalInspec Solutions LLC.72667-283
DCH Labs Cool and Heat Roll-Onmenthol 16%Menthol 16 g/100gLiquidTopicalDerma Care Research Labs, LLC72839-101
Mineral Ice Extreme Dry StickmentholMenthol 16 g/100gStickTopicalCarlin Consumer Health LLC82632-250
Thera Plus Maximum Strength HydrocortisonehydrocortisoneHydrocortisone 10 mg/gCreamTopicalFourstar Group USA, Inc80684-197
Sylvirene Numbingmenthol 5% numbingMenthol 5 g/100gCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-163
PHIZICO Pain ReliefmentholMenthol 10 mg/mLCreamTopicalER3 BRANDS INC.85832-621
Arthritis Relief GoodSensetrolamine salicylateTrolamine salicylate 10 g/100gCreamTopicalGeiss, Destin & Dunn, Inc50804-207
Sore No More Cool TherapymentholMenthol .06 g/gGelTopicalSOMBRA COSMETICS INC.61577-3235
Maximum Strength Cortisone Cream with Aloehydrocortisone creamHydrocortisone 1 g/100gCreamTopicalCVS Pharmacy69842-630
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnmentholMenthol 6 g/100gGelTopicalInspec Solutions72667-073
Mineral Ice Extreme Menthol Pain ReliefmentholMenthol 105 mg/mLLiquidTopicalCarlin Consumer Health LLC82632-252
Lidocainelidocaine, mentholLidocaine .4 g/10g; Menthol .1 g/10gPatchTransdermalVive Health LLC84722-3041
Serynth Nicotine Transdermal Stop Smoking Aidnicotine21mg nicotine transdermal stop smoking aidNicotine 21 mg/1001PatchTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-164
Astrapharm Chilli BrandcapsaicinCapsaicin .25 g/100gPlasterTopicalDersan Pharmaceutical Co., Ltd11993-000
HydrocortisoneHydrocortisone 1 g/100gCreamTopicalEncube Ethicals, Inc.21922-096
hydrocortisoneHydrocortisone 1 g/100gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-438
Zims Max Freeze Pro Formulamenthol, unspecified formMenthol, Unspecified form 70 mg/gGelTopicalKOBAYASHI Healthcare International, Inc.54273-006
Re-LevementholMenthol .06 g/gGelTopicalSOMBRA COSMETICS INC.61577-3242

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