NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8791Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8791Add 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
63629-8791-163629879101636298791011 TUBE in 1 CARTON (63629-8791-1) / 45 g in 1 TUBEMarketed from Jun 30, 2010

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)
Adapalene
Generic name (nonproprietary)
adapalene
Active ingredients
Adapalene — 1 mg/g
Dosage form
Cream
Route
Topical
Labeler
Bryant Ranch PrepackNDC labeler code 63629
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 63629-8791_33b3377c-cc50-4734-8cfe-e6d828631856SPL ID 33b3377c-cc50-4734-8cfe-e6d828631856SPL set ID 5f8189a2-a7ec-441b-993c-fed28b3ae24fRxCUI 313852UNII 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

N463629879101 followed by a unit qualifier and the quantity

Package 63629-8791-01. 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)

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 63629-8791

What is NDC 63629-8791?
63629-8791 is the product NDC for Adapalene, Adapalene 1 mg/g cream, 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?
Adapalene.
What is the active ingredient?
Adapalene.
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 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/gCreamTopicalE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC0168-0424
AdapaleneAdapalene 1 mg/gCreamTopicalBryant Ranch Prepack72162-1048

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