NDC codes

FDA NDC Directory
Product NDC (as listed)68462-859Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0859Add 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
68462-859-2468462085924684620859241 BOTTLE, PUMP in 1 CARTON (68462-859-24) / 35 g in 1 BOTTLE, PUMPMarketed from Sep 24, 2021
68462-859-2768462085927684620859271 BOTTLE, PUMP in 1 CARTON (68462-859-27) / 50 g in 1 BOTTLE, PUMPMarketed from Sep 24, 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
Active ingredients
Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 50 mg/g
Dosage form
Gel
Route
Topical
Labeler
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209252
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 68462-859_03e34592-8f1e-49cd-8a20-824d2b18b4b5SPL ID 03e34592-8f1e-49cd-8a20-824d2b18b4b5SPL set ID 76795d1b-e1f2-4d1d-b42a-f1d4448c63c0RxCUI 358917UNII W9WZN9A0GM, EH6D7113I8UPC 0368462859247, 0368462857861, 0368462484692, 0368462484869, 0368462484982
Pharmacologic class
Lincosamide Antibacterial

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

N468462085924 followed by a unit qualifier and the quantity

Package 68462-0859-24. 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 Gel 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 68462-859

What is NDC 68462-859?
68462-859 is the product NDC for clindamycin and benzoyl peroxide, Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g gel, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
clindamycin and benzoyl peroxide.
What is the active ingredient?
Clindamycin phosphate, Benzoyl peroxide.
Who is the labeler?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 peroxide—KitPadagis Israel Pharmaceuticals Ltd45802-51045802-0510-03
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 209252

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

FDA NDC Directory listings under ANDA 209252
ProductStrengthForm · routeLabelerProduct NDC
clindamycin and benzoyl peroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/gGelTopicalNorthStar RxLLC16714-984
clindamycin and benzoyl peroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/gGelTopicalGlenmark Pharmaceuticals Inc., USA68462-486

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