NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1716Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1716Add 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
70771-1716-370771171603707711716031 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-3) / 60 g in 1 BOTTLE, PUMPMarketed from Jun 6, 2022
70771-1716-470771171604707711716041 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-4) / 45 g in 1 BOTTLE, PUMPMarketed from Jun 6, 2022

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 and benzoyl peroxide
Generic name (nonproprietary)
adapalene and benzoyl peroxide
Active ingredients
Adapalene — 3 mg/gBenzoyl peroxide — 25 mg/g
Dosage form
Gel
Route
Topical
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214553
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 70771-1716_2825a88e-4c88-4703-9128-ad478f3aae28SPL ID 2825a88e-4c88-4703-9128-ad478f3aae28SPL set ID d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5RxCUI 1663745UNII 1L4806J2QF, W9WZN9A0GM
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

N470771171603 followed by a unit qualifier and the quantity

Package 70771-1716-03. 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 70771-1716

What is NDC 70771-1716?
70771-1716 is the product NDC for Adapalene and benzoyl peroxide, Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g gel, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Adapalene and benzoyl peroxide.
What is the active ingredient?
Adapalene, Benzoyl peroxide.
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 Adapalene and benzoyl peroxide?
15 other product NDCs are listed under this name. See all Adapalene and benzoyl peroxide 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 and benzoyl peroxide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Adapalene and benzoyl peroxideAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalAurobindo Pharma Limited59651-60459651-0604-4659651-0604-60
Adapalene And Benzoyl Peroxideadapalene and benzoyl peroxide topicalAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalAlembic Pharmaceuticals Limited46708-66246708-0662-45
Adapalene and benzoyl peroxideAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalTeva Pharmaceuticals, Inc.0480-315400480-3154-45
Adapalene And Benzoyl Peroxideadapalene and benzoyl peroxide topicalAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalAlembic Pharmaceuticals Inc.62332-66262332-0662-45
Adapalene and benzoyl peroxideAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalViona Pharmaceuticals Inc72578-11972578-0119-0272578-0119-04
Adapalene And Benzoyl PeroxideAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-85345802-0853-45
Adapalene And Benzoyl PeroxideAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalBryant Ranch Prepack63629-932263629-9322-01
Adapalene And Benzoyl PeroxideAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalBryant Ranch Prepack72162-143272162-1432-02
adapalene and benzoyl peroxideAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalMayne Pharma Inc.68308-66268308-0662-45
adapalene and benzoyl peroxideAdapalene 1 mg/g; Benzoyl peroxide 25 mg/gGelTopicalGlenmark Pharmaceuticals Inc., USA68462-30168462-0301-4768462-0301-55

All 16 Adapalene and benzoyl peroxide NDCs

Other NDCs under ANDA 214553

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

FDA NDC Directory listings under ANDA 214553
ProductStrengthForm · routeLabelerProduct NDC
Adapalene and benzoyl peroxideAdapalene 3 mg/g; Benzoyl peroxide 25 mg/gGelTopicalViona Pharmaceuticals Inc72578-119

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