NDC codes

FDA NDC Directory
Product NDC (as listed)0168-0424Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00168-0424Add 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
0168-0424-4600168042446001680424461 TUBE in 1 CARTON (0168-0424-46) / 45 g in 1 TUBEMarketed from Jun 30, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Adapalene
Generic name (nonproprietary)
adapalene
Active ingredients
Adapalene — 1 mg/g
Dosage form
Cream
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090824
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 0168-0424_3704e230-6ad8-448d-a4bf-a86c449837b9SPL ID 3704e230-6ad8-448d-a4bf-a86c449837b9SPL set ID 276f7cce-5f54-40f8-8321-9192d0e52a73RxCUI 313852UNII 1L4806J2QFUPC 0301680424460
Pharmacologic class
Retinoid

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

N400168042446 followed by a unit qualifier and the quantity

Package 00168-0424-46. 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)

INDICATIONS AND USAGE: Adapalene cream is indicated for the topical treatment of acne vulgaris.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0168-0424

What is NDC 0168-0424?
0168-0424 is the product NDC for Adapalene, Adapalene 1 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Adapalene.
What is the active ingredient?
Adapalene.
Who is the labeler?
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Adapalene?
35 other product NDCs are listed under this name. See all Adapalene 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 Adapalene NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AdapaleneAdapalene 1 mg/gGelTopicalYYBA Corp73581-21673581-0216-45
AdapaleneAdapalene 1 mg/gGelTopicalYYBA CORP73581-21573581-0215-45
AdapaleneAdapalene 1 mg/gGelTopicalWalgreens0363-411000363-4110-0500363-4110-16
AdapaleneAdapalene 1 mg/gGelTopicalWal-Mart Stores Inc79903-33879903-0338-05
AdapaleneAdapalene 3 mg/gGelTopicalAlembic Pharmaceuticals Limited46708-54946708-0549-1546708-0549-4546708-0549-46
AdapaleneAdapalene 1 mg/gGelTopicalYYBA Corp73581-01973581-0019-06
AdapaleneAdapalene 1 mg/gGelTopicalTarget Corporation82442-10582442-0105-01
AdapaleneAdapalene 1 mg/gGelTopicalRITE AID11822-006211822-0062-01
AdapaleneAdapalene 1 mg/gGelTopicalCardinal Health70000-066670000-0666-0170000-0666-02
AdapaleneAdapalene 1 mg/gGelTopicalThe Kroger Co.30142-72530142-0725-05

All 36 Adapalene NDCs

Other NDCs under ANDA 090824

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

FDA NDC Directory listings under ANDA 090824
ProductStrengthForm · routeLabelerProduct NDC
AdapaleneAdapalene 1 mg/gCreamTopicalBryant Ranch Prepack63629-8791
AdapaleneAdapalene 1 mg/gCreamTopicalBryant Ranch Prepack72162-1048

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