NDC codes

FDA NDC Directory
Product NDC (as listed)16714-984Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0984Add 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
16714-984-25167140984251 JAR in 1 CARTON (16714-984-25) / 25 g in 1 JARMarketed from Jul 1, 2019
16714-984-50167140984501 JAR in 1 CARTON (16714-984-50) / 50 g in 1 JARMarketed from Jul 1, 2019

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
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 16714-984_35611701-add1-42d0-9fc2-58368001602aSPL ID 35611701-add1-42d0-9fc2-58368001602aSPL set ID e19de12c-f29b-42ab-9e81-1af8e4a66643RxCUI 358917UNII EH6D7113I8, W9WZN9A0GMUPC 0316714984254, 0316714982021
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

N416714098425 followed by a unit qualifier and the quantity

Package 16714-0984-25. 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)

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/gGelTopicalGlenmark Pharmaceuticals Inc., USA68462-486
clindamycin and benzoyl peroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/gGelTopicalGlenmark Pharmaceuticals Inc., USA68462-859

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