NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8634Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8634Add 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
63629-8634-1636298634011 BOTTLE, WITH APPLICATOR in 1 CARTON (63629-8634-1) / 60 mL in 1 BOTTLE, WITH APPLICATORMarketed from Sep 17, 2013

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)
Clindamycin Phosphate
Generic name (nonproprietary)
clindamycin phosphate
Active ingredients
Clindamycin phosphate — 10 mg/mL
Dosage form
Solution
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 064050
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 63629-8634_d613ad30-0730-44ee-97c1-105881d3d194SPL ID d613ad30-0730-44ee-97c1-105881d3d194SPL set ID c22fb382-afbc-4b2d-bdce-e97e21bddb23RxCUI 309333UNII EH6D7113I8
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

N463629863401 followed by a unit qualifier and the quantity

Package 63629-8634-01. 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 Topical Solution USP, 1% 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 064050

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

FDA NDC Directory listings under ANDA 064050
ProductStrengthForm · routeLabelerProduct NDC
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalPadagis Israel Pharmaceuticals Ltd45802-562
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalBryant Ranch Prepack71335-2861
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalBryant Ranch Prepack71335-2863
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalBryant Ranch Prepack72162-1418
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalBryant Ranch Prepack63629-8633
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalA-S Medication Solutions50090-2611

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