NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1874Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1874Add 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
70771-1874-77077118740770771187407120 mL in 1 BOTTLE (70771-1874-7)Marketed from Mar 8, 2025

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 — 20 mg/mL
Dosage form
Shampoo
Route
Topical
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218559
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 70771-1874_9795147c-bca9-481c-b910-edee5bdd5f29SPL ID 9795147c-bca9-481c-b910-edee5bdd5f29SPL set ID c004ee91-558a-450b-9e4e-d11ab9d28054RxCUI 106336UNII R9400W927IUPC 0372578156121, 0015100006807
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

N470771187407 followed by a unit qualifier and the quantity

Package 70771-1874-07. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1874

What is NDC 70771-1874?
70771-1874 is the product NDC for Ketoconazole, Ketoconazole 20 mg/mL shampoo, listed with the FDA by Zydus Lifesciences Limited. 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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/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
Ketoconazoleketoconazole cream, 2%Ketoconazole 20 mg/gCreamTopicalREMEDYREPACK INC.70518-423670518-4236-00

All 55 Ketoconazole NDCs

Other NDCs under ANDA 218559

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

FDA NDC Directory listings under ANDA 218559
ProductStrengthForm · routeLabelerProduct NDC
KetoconazoleKetoconazole 20 mg/mLShampooTopicalViona Pharmaceuticals Inc72578-156

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