Clindamycin Phosphate NDC 45802-128

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-128Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0128Add 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 NDC	11-digit (billing)	Package	Copy
45802-128-01	45802012801	60 mL in 1 BOTTLE (45802-128-01)Marketed from Mar 31, 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/mL
Dosage form: Lotion
Route: Topical
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214604
Marketing start: Mar 31, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 45802-128_073ff89e-39d5-4061-9af6-7fa356b2fce5SPL ID 073ff89e-39d5-4061-9af6-7fa356b2fce5SPL set ID a10dda0c-28fa-4678-8cea-a6ce2fce4b52RxCUI 197519UNII 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

N445802012801 followed by a unit qualifier and the quantity

Package 45802-0128-01. 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 Sep 1, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clindamycin phosphate topical lotion 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 214604

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

FDA NDC Directory listings under ANDA 214604
Product	Strength	Form · route	Labeler	Product NDC
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	LotionTopical	Bryant Ranch Prepack	72162-1395
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	LotionTopical	Bryant Ranch Prepack	71335-2953
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	LotionTopical	Bryant Ranch Prepack	63629-8632
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	LotionTopical	Bryant Ranch Prepack	63629-9459