NDC codes

FDA NDC Directory
Product NDC (as listed)43538-172Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43538-0172Add 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
43538-172-60435380172604353801726060 PACKET in 1 CARTON (43538-172-60) / 1 SWAB in 1 PACKETMarketed from Jun 15, 2013
43538-172-99435380172994353801729912 PACKET in 1 CARTON (43538-172-99) / 1 SWAB in 1 PACKETMarketed from Oct 24, 2023

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)
Clindacin ETZ
Generic name (nonproprietary)
clindamycin phosphate
Active ingredients
Clindamycin phosphate — 10 mg/1
Dosage form
Swab
Route
Topical
Labeler
Eurofarma, Inc.NDC labeler code 43538
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065049
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 43538-172_24aae3bd-54de-429d-9587-c156b5949f40SPL ID 24aae3bd-54de-429d-9587-c156b5949f40SPL set ID 89fed26e-1cad-4c0b-8695-d6f3562ba8d5RxCUI 797274, 1091339UNII 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

N443538017260 followed by a unit qualifier and the quantity

Package 43538-0172-60. 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 Clindacin ® ETZ 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)

About NDC 43538-172

What is NDC 43538-172?
43538-172 is the product NDC for Clindacin ETZ (clindamycin phosphate), Clindamycin phosphate 10 mg/1 swab, listed with the FDA by Eurofarma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clindacin ETZ (Clindamycin phosphate).
What is the active ingredient?
Clindamycin phosphate.
Who is the labeler?
Eurofarma, Inc., NDC labeler code 43538. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clindacin ETZ?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 065049

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

FDA NDC Directory listings under ANDA 065049
ProductStrengthForm · routeLabelerProduct NDC
Clindacin Pclindamycin phosphateClindamycin phosphate 10 mg/mLSolutionTopicalEurofarma, Inc.43538-170
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalPadagis Israel Pharmaceuticals Ltd45802-263
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalA-S Medication Solutions50090-1932

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