NDC codes

FDA NDC Directory
Product NDC (as listed)16714-161Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0161Add 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
16714-161-01167140161011 TUBE in 1 CARTON (16714-161-01) / 30 g in 1 TUBEMarketed from Mar 10, 2021
16714-161-02167140161021 TUBE in 1 CARTON (16714-161-02) / 60 g in 1 TUBEMarketed from Mar 10, 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 Phosphate
Generic name (nonproprietary)
clindamycin phosphate
Active ingredients
Clindamycin phosphate — 10 mg/g
Dosage form
Gel
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214251
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 16714-161_bc7bd8b3-2edc-4477-82ae-096e6e5bfde0SPL ID bc7bd8b3-2edc-4477-82ae-096e6e5bfde0SPL set ID 62e1661f-1eab-4693-8cce-c22f572baa7fRxCUI 2676585UNII EH6D7113I8UPC 0316714161013
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

N416714016101 followed by a unit qualifier and the quantity

Package 16714-0161-01. 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 Clindamycin phosphate gel is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214251

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

FDA NDC Directory listings under ANDA 214251
ProductStrengthForm · routeLabelerProduct NDC
Clindamycin PhosphateClindamycin phosphate 10 mg/gGelTopicalA-S Medication Solutions50090-6072
Clindamycin PhosphateClindamycin phosphate 10 mg/gGelTopicalGLENMARK PHARMACEUTICALS INC., USA68462-866

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