What is NDC 43538-176?

43538-176 is the product NDC for Neuac, Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g gel, listed with the FDA by Medimetriks Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Clindamycin phosphate, Benzoyl peroxide.

Medimetriks Pharmaceuticals, 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 Neuac?

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.

Neuac NDC 43538-176 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43538-176Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43538-0176Add 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
43538-176-45	4353801764543538017645	1 TUBE in 1 CARTON (43538-176-45) / 45 g in 1 TUBEMarketed from Jun 15, 2014

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): Neuac
Generic name (nonproprietary): clindamycin phosphate and benzoyl peroxide
Active ingredients: Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 50 mg/g
Dosage form: Gel
Route: Topical
Labeler: Medimetriks PharmaceuticalsNDC labeler code 43538
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090979
Marketing start: Jun 15, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 43538-176_ea93a8c5-1172-4b62-9a28-33783fbca9fdSPL ID ea93a8c5-1172-4b62-9a28-33783fbca9fdSPL set ID e2cd1c2a-00ee-465e-a4f4-9c0a0bc6266fRxCUI 1540241, 1540246UNII EH6D7113I8, W9WZN9A0GM
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

N443538017645 followed by a unit qualifier and the quantity

Package 43538-0176-45. 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 Nov 15, 2023.

Indications (excerpt from the label)

Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. ( 1.1 ) Limitation of Use: Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. ( 1.2 ) 1.1 Indication Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. 1.2 Limitations of…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43538-176

What is NDC 43538-176?: 43538-176 is the product NDC for Neuac, Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g gel, listed with the FDA by Medimetriks Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Neuac (Clindamycin phosphate and benzoyl peroxide).
What is the active ingredient?: Clindamycin phosphate, Benzoyl peroxide.
Who is the labeler?: Medimetriks Pharmaceuticals, 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 Neuac?: 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 090979

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

FDA NDC Directory listings under ANDA 090979
Product	Strength	Form · route	Labeler	Product NDC
clindamycin phosphate and benzoyl peroxideclindamycin, benzoyl peroxide	Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-736