Over-the-counter drug · OTC MONOGRAPH DRUG

Hydrocortisone 1% (Hydrocortisone) NDC 69396-050

Hydrocortisone 1 g/100g · Cream · Topical · Trifecta Pharmaceuticals Usa Llc

NDC codes

FDA NDC Directory
Product NDC (as listed)69396-050Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69396-0050Add 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
69396-050-01693960050011 TUBE in 1 BOX (69396-050-01) / 28.4 g in 1 TUBEMarketed from Dec 12, 2019
69396-050-05693960050051 TUBE in 1 BOX (69396-050-05) / 14.2 g in 1 TUBEMarketed from Sep 1, 2022

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 1%
Generic name (nonproprietary)
hydrocortisone
Active ingredients
Hydrocortisone — 1 g/100g
Dosage form
Cream
Route
Topical
Labeler
Trifecta Pharmaceuticals Usa LlcNDC labeler code 69396
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 69396-050_4c363aee-bd3b-680f-e063-6294a90a283bSPL ID 4c363aee-bd3b-680f-e063-6294a90a283bSPL set ID 9987165c-1a0f-dd57-e053-2a95a90ae735RxCUI 106258UNII WI4X0X7BPJUPC 0860001004939
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

N469396005001 followed by a unit qualifier and the quantity

Package 69396-0050-01. 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 temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: ● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps ● detergents ● cosmetics ● jewelry ● external feminine genital and anal itching Other uses of this product should be only under the advice 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 69396-050

What is NDC 69396-050?
69396-050 is the product NDC for Hydrocortisone 1% (hydrocortisone), Hydrocortisone 1 g/100g cream, listed with the FDA by Trifecta Pharmaceuticals Usa Llc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocortisone 1% (Hydrocortisone).
What is the active ingredient?
Hydrocortisone.
Who is the labeler?
Trifecta Pharmaceuticals Usa Llc, NDC labeler code 69396. 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 1%?
13 other product NDCs are listed under this name. See all Hydrocortisone 1% 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 1% NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalPreferred Pharmaceuticals Inc.68788-410968788-4109-02
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalProStat First Aid58228-702058228-7020-01
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalProStat First Aid58228-703058228-7030-01
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalChain Drug Marketing Association Inc.83324-32983324-0329-01
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalChain Drug Marketing Association Inc.83324-04783324-0047-01
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalTrifecta Pharmaceuticals Usa Llc69396-12969396-0129-01
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalTrifecta Pharmaceuticals Usa Llc69396-11869396-0118-0969396-0118-25
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalGeri-Care Pharmaceuticals, Corp57896-14657896-0146-14
Hydrocortisone 1%Hydrocortisone 1 g/100gCreamTopicalProStat First Aid LLC58228-204558228-2045-02
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalTrifecta Pharmaceuticals Usa Llc69396-08169396-0081-01

All 14 Hydrocortisone 1% 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
Rite Aid Hydrocortisonehydrocortisone 1%Hydrocortisone 1 g/100gOintmentTopicalRite Aid11822-2685
Flanaxmethyl salicylate, menthol, capsaicinMethyl salicylate 28 g/100g + 2 more ingredientsLinimentTopicalBelmora LLC27854-499
Profoot Pain Relief Patchescamphor, menthol, methyl salicylate—KitRooftop Consumer Health, Inc.29784-600
Eagle Medicatedmenthol methyl salicylateMethyl salicylate 30 g/100mL; Menthol 14.5 g/100mLOilTopicalBorden Company (Private) Limited43405-008
Burn Relief Aloelidocaine hclLidocaine hydrochloride 4 g/100gGelTopicalAcutens80551-001
Large Pain Relievingcamphor menthol methyl salicytateCamphor (Synthetic) 3.1 g/100g + 2 more ingredientsPatchTopicalWalgreen Company0363-9904
Teeter Renew Muscles Pain Relievingmethyl salicylate, mentholMethyl salicylate 100 mg/mL; Menthol 70 mg/mLCreamTopicalSTL International INC70329-730
Nufabrx Medicine Infused SockscapsaicinCapsaicin .12 g/100gClothTopicalNufabrx LLC72490-037
BurnlidocaineLidocaine hydrochloride 2 mg/100mLSprayTopicalHART Health50332-0210
Pramoxine Itch reliefpramoxine hcl 1%Pramoxine hydrochloride 1 g/100gCreamTopicalCVS51316-141
DG Health Hydrocortisone Maximum StrengthhydrocortisoneHydrocortisone 1 g/100gCreamTopicalDolgencorp Inc55910-319
Methyl Salicylate 10% Pain Relievingmethyl salicylateMethyl salicylate 100 mg/gCreamTopicalPureTek Corporation59088-243
BiofreezementholMenthol 105 mg/mLSprayTopicalReckitt Benckiser LLC59316-833
Qr PainanalgesicMannitol 30 g/100g; Menthol 1.25 g/100gCreamTopicalMARYHELENE ENTERPRISES INC73180-005
Methyl Salicylate 25% Creammethyl salicylateMethyl salicylate 250 mg/mLCreamTopicalMedcore LLC82461-415
Profoot Pain Relief Patchescamphor, menthol, methyl salicylate—KitProfoot, Inc.29784-601
Lidocaineburn reliefLidocaine .64 g/127gAerosol, SprayTopicalFoodhold USA41520-162
Eagle Medicated Aromaticcamphor menthol methyl salicylateCamphor (Synthetic) 7 g/100mL + 2 more ingredientsOilTopicalBorden Company (Private) Limited43405-009
HydrocortisoneHydrocortisone 10 mg/gCreamTopicalUnifirst First Aid Corporation47682-933
Arctic Heatmenthol, methyl salicylateMethyl salicylate 11.2 g/112g; Menthol 2.24 g/112gCreamTopicalRenu Laboratories, LLC76348-414

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