NDC codes

FDA NDC Directory
Product NDC (as listed)45802-510Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45802-0510Add 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
45802-510-0345802051003458020510031 KIT in 1 CARTON (45802-510-03) * .4 g in 1 VIAL (45802-738-03) * 27.6 g in 1 BOTTLE, PUMP (45802-998-03)Marketed from Mar 8, 2021

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)
clindamycin and benzoyl peroxide
Generic name (nonproprietary)
clindamycin and benzoyl peroxide
Dosage form
Kit
Labeler
Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202440
Marketing start
Listing expires
Identifiers
Product ID 45802-510_84f65326-838e-412d-a5b4-44a28cea1415SPL ID 84f65326-838e-412d-a5b4-44a28cea1415SPL set ID 6bf0f3e5-6ad7-4791-9483-0977b18ad77fRxCUI 358917

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N445802051003 followed by a unit qualifier and the quantity

Package 45802-0510-03. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Clindamycin and benzoyl peroxide topical gel, 1%/5% 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 45802-510

What is NDC 45802-510?
45802-510 is the product NDC for clindamycin and benzoyl peroxide kit, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
clindamycin and benzoyl peroxide.
Who is the labeler?
Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for clindamycin and benzoyl peroxide?
7 other product NDCs are listed under this name. See all clindamycin 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 clindamycin and benzoyl peroxide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Clindamycin and Benzoyl Peroxide—KitEncube Ethicals, Inc.21922-06821922-0068-4321922-0068-4421922-0068-45+1 more
clindamycin and benzoyl peroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/gGelTopicalGlenmark Pharmaceuticals Inc., USA68462-85968462-0859-2468462-0859-27
clindamycin and benzoyl peroxide—KitPadagis Israel Pharmaceuticals Ltd45802-50945802-0509-01
clindamycin and benzoyl peroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/gGelTopicalNorthStar RxLLC16714-98416714-0984-2516714-0984-50
clindamycin and benzoyl peroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/gGelTopicalGlenmark Pharmaceuticals Inc., USA68462-48668462-0486-1968462-0486-2468462-0486-27
Clindamycin And Benzoyl Peroxide—KitPadagis Israel Pharmaceuticals Ltd45802-50745802-0507-02
Clindamycin And Benzoyl Peroxide—KitBryant Ranch Prepack72162-207472162-2074-02

Other NDCs under ANDA 202440

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

FDA NDC Directory listings under ANDA 202440
ProductStrengthForm · routeLabelerProduct NDC
Clindamycin And Benzoyl Peroxide—KitPadagis Israel Pharmaceuticals Ltd45802-507
clindamycin and benzoyl peroxide—KitPadagis Israel Pharmaceuticals Ltd45802-509
Clindamycin And Benzoyl Peroxide—KitBryant Ranch Prepack72162-2074

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