NDC codes

FDA NDC Directory
Product NDC (as listed)46122-768Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46122-0768Add 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
46122-768-3646122076836461220768361 TUBE in 1 CARTON (46122-768-36) / 15 g in 1 TUBEMarketed from Feb 26, 2024

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)
Adapalene
Generic name (nonproprietary)
adapalene
Active ingredients
Adapalene — 1 mg/g
Dosage form
Gel
Route
Topical
Labeler
AMERISOURCE BERGENNDC labeler code 46122
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215940
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 46122-768_38f457fa-0e98-7298-e063-6394a90adda8SPL ID 38f457fa-0e98-7298-e063-6394a90adda8SPL set ID 8d6e2e28-a11a-4443-a43b-098a55622e24RxCUI 307731UNII 1L4806J2QF
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

N446122076836 followed by a unit qualifier and the quantity

Package 46122-0768-36. 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)

Use For the treatment of acne

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46122-768

What is NDC 46122-768?
46122-768 is the product NDC for Adapalene, Adapalene 1 mg/g gel, listed with the FDA by AMERISOURCE BERGEN. 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?
AMERISOURCE BERGEN, NDC labeler code 46122. 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 215940

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

FDA NDC Directory listings under ANDA 215940
ProductStrengthForm · routeLabelerProduct NDC
AdapaleneAdapalene 1 mg/gGelTopicalRUGBY LABORATORIES, INC.0536-1412
AdapaleneAdapalene 1 mg/gGelTopicalRITE AID11822-0062
AdapaleneAdapalene 1 mg/gGelTopicalSun Pharmaceutical Industries, Inc.51672-2150
AdapaleneAdapalene 1 mg/gGelTopicalCardinal Health70000-0666
AdapaleneAdapalene 1 mg/gGelTopicalYYBA Corp73581-019
AdapaleneAdapalene 1 mg/gGelTopicalYYBA CORP73581-214
AdapaleneAdapalene 1 mg/gGelTopicalWal-Mart Stores Inc79903-338
AdapaleneAdapalene 1 mg/gGelTopicalTarget Corporation82442-105
PanOxyladapaleneAdapalene 1 mg/gGelTopicalCROWN LABORATORIES0316-0143
PanOxyladapaleneAdapalene 1 mg/gGelTopicalCROWN LABORATORIES0316-0284
Proactiv MD Adapalene Acne TreatmentadapaleneAdapalene .1 g/100gGelTopicalAlchemee, LLC11410-958

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