Klaron (sulfacetamide sodium) NDC 0187-5198

NDC codes

FDA NDC Directory

Product NDC (as listed)0187-5198Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00187-5198Add 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
0187-5198-04	00187519804	1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) / 118 mL in 1 BOTTLE, PLASTICMarketed from Dec 23, 1996

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Klaron
Generic name (nonproprietary): sulfacetamide sodium
Active ingredients: Sulfacetamide sodium — 100 mg/mL
Dosage form: Lotion
Route: Topical
Labeler: Bausch Health US, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019931
Marketing start: Dec 23, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Sulfonamides (Chemical structure)
Identifiers: Product ID 0187-5198_4dd0038b-2f5d-436c-8a6d-6db44760c37aSPL ID 4dd0038b-2f5d-436c-8a6d-6db44760c37aSPL set ID 66ab38ea-5cea-47be-97f2-486517999fb0RxCUI 1006688, 1006693UNII 4NRT660KJQ
Pharmacologic class: Sulfonamide 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

N400187519804 followed by a unit qualifier and the quantity

Package 00187-5198-04. 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 Aug 31, 2020.

Indications (excerpt from the label)

INDICATIONS Klaron Lotion is indicated in 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 NDA 019931

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

FDA NDC Directory listings under NDA 019931
Product	Strength	Form · route	Labeler	Product NDC
Sodium sulfacetamide	Sulfacetamide sodium 100 mg/mL	LotionTopical	Oceanside Pharmaceuticals	68682-010