Prescription drug · ANDA

ketoconazole NDC 63629-8677

Ketoconazole 2 g/100g · Aerosol, Foam · Topical · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8677Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8677Add 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
63629-8677-163629867701636298677011 CANISTER in 1 CARTON (63629-8677-1) / 100 g in 1 CANISTERMarketed from Aug 30, 2011

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
ketoconazole
Generic name (nonproprietary)
ketoconazole
Active ingredients
Ketoconazole — 2 g/100g
Dosage form
Aerosol, Foam
Route
Topical
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091550
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 63629-8677_6e2c78c5-12df-445d-a2ec-d25482b4ecd8SPL ID 6e2c78c5-12df-445d-a2ec-d25482b4ecd8SPL set ID 77989858-9f7a-45d6-97fb-deba1cba8fe8RxCUI 728550UNII R9400W927I
Pharmacologic class
Azole Antifungal

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

N463629867701 followed by a unit qualifier and the quantity

Package 63629-8677-01. 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)

Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established. Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older ( 1 ). Limitations of Use Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8677

What is NDC 63629-8677?
63629-8677 is the product NDC for ketoconazole, Ketoconazole 2 g/100g aerosol, foam, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ketoconazole.
What is the active ingredient?
Ketoconazole.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ketoconazole?
54 other product NDCs are listed under this name. See all ketoconazole 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 ketoconazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
KetoconazoleKetoconazole 20 mg/gCreamTopicalIPG PHARMACEUTICALS, INC.71085-00871085-0008-45
KetoconazoleKetoconazole 200 mg/1TabletOralAmerisyn LLC87564-05187564-0051-1087564-0051-30
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalNuCare Pharmaceuticals, Inc.68071-529468071-5294-04
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalNorthstar Rx LLC72603-87872603-0878-01
KetoconazoleKetoconazole 200 mg/1TabletOralAmici Pharma Inc.69292-22469292-0224-01
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalPreferred Pharmaceuticals Inc.68788-886868788-8868-01
KetoconazoleKetoconazole 20 mg/mLShampooTopicalZydus Lifesciences Limited70771-187470771-1874-07
KetoconazoleKetoconazole 20 mg/mLShampooTopicalViona Pharmaceuticals Inc72578-15672578-0156-12
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalCosette Pharmaceuticals, Inc.0713-059200713-0592-04
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalA-S Medication Solutions50090-753850090-7538-00

All 55 ketoconazole NDCs

Other NDCs under ANDA 091550

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

FDA NDC Directory listings under ANDA 091550
ProductStrengthForm · routeLabelerProduct NDC
ketoconazoleKetoconazole 2 g/100gAerosol, FoamTopicalPadagis Israel Pharmaceuticals Ltd45802-532
ketoconazoleKetoconazole 2 g/100gAerosol, FoamTopicalBryant Ranch Prepack63629-8676
ketoconazoleKetoconazole 2 g/100gAerosol, FoamTopicalBryant Ranch Prepack71335-2941
ketoconazoleKetoconazole 2 g/100gAerosol, FoamTopicalBryant Ranch Prepack71335-2943
ketoconazoleKetoconazole 2 g/100gAerosol, FoamTopicalBryant Ranch Prepack72162-1417
KetodanketoconazoleKetoconazole 20 mg/gAerosol, FoamTopicalMedimetriks Pharmaceuticals, Inc.43538-530

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in