NDC codes

FDA NDC Directory
Product NDC (as listed)68682-384Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68682-0384Add 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
68682-384-4568682038445686820384451 TUBE in 1 CARTON (68682-384-45) / 45 g in 1 TUBEMarketed from Jul 3, 2013
68682-384-6068682038460686820384601 TUBE in 1 CARTON (68682-384-60) / 60 g in 1 TUBEMarketed from Jul 3, 2013

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 Butyrate
Generic name (nonproprietary)
hydrocortisone butyrate
Active ingredients
Hydrocortisone butyrate — 1 mg/g
Dosage form
Cream
Route
Topical
Labeler
Oceanside PharmaceuticalsNDC labeler code 68682
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 020769
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 68682-384_36d82d8e-8303-bf39-e063-6394a90a2fabSPL ID 36d82d8e-8303-bf39-e063-6394a90a2fabSPL set ID ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1RxCUI 1370770UNII 05RMF7YPWN
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

N468682038445 followed by a unit qualifier and the quantity

Package 68682-0384-45. 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)

Hydrocortisone Butyrate Cream (lipid), 0.1% is indicated for: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older. Hydrocortisone Butyrate Cream (lipid), 0.1% is a corticosteroid indicated for: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. ( 1 ) The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68682-384

What is NDC 68682-384?
68682-384 is the product NDC for Hydrocortisone Butyrate, Hydrocortisone butyrate 1 mg/g cream, listed with the FDA by Oceanside Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocortisone Butyrate.
What is the active ingredient?
Hydrocortisone butyrate.
Who is the labeler?
Oceanside Pharmaceuticals, NDC labeler code 68682. 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 Butyrate?
7 other product NDCs are listed under this name. See all Hydrocortisone Butyrate 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 Butyrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydrocortisone ButyrateHydrocortisone butyrate 1 mg/mLLotionTopicalBryant Ranch Prepack72162-263072162-2630-0272162-2630-04
Hydrocortisone ButyrateHydrocortisone butyrate 1 mg/mLLotionTopicalThe J. Molner Company LLC83148-01283148-0012-0283148-0012-04
Hydrocortisone ButyrateHydrocortisone butyrate 1 mg/mLLotionTopicalLupin Pharmaceuticals, Inc.68180-95168180-0951-0168180-0951-02
Hydrocortisone ButyrateHydrocortisone butyrate 1 mg/gOintmentTopicalOceanside Pharmaceuticals68682-27168682-0271-1568682-0271-45
Hydrocortisone ButyrateHydrocortisone butyrate 1 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-407451672-4074-0151672-4074-0251672-4074-05+2 more
Hydrocortisone ButyrateHydrocortisone butyrate 1 mg/gOintmentTopicalSun Pharmaceutical Industries, Inc.51672-408351672-4083-0151672-4083-0251672-4083-05+2 more
Hydrocortisone ButyrateHydrocortisone butyrate 1 mg/mLSolutionTopicalSun Pharmaceutical Industries, Inc.51672-406151672-4061-0251672-4061-04

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