Acitretin NDC 42794-080

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0080Add 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
42794-080-08	42794008008	30 CAPSULE in 1 BOTTLE (42794-080-08)Marketed from Sep 16, 2015

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): Acitretin
Generic name (nonproprietary): acitretin
Active ingredients: Acitretin — 10 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sigmapharm Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204633
Marketing start: Sep 16, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 42794-080_57aea59c-767d-0301-e063-6294a90a9d9aSPL ID 57aea59c-767d-0301-e063-6294a90a9d9aSPL set ID a6546625-acb8-460e-b34e-f795bfb3680aRxCUI 199689, 199690, 894859UNII LCH760E9T7UPC 0342794083082, 0342794081088, 0342794080081
Pharmacologic class: Retinoid

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442794008008 followed by a unit qualifier and the quantity

Package 42794-0080-08. 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 5, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules, USP should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules, USP can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204633

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

FDA NDC Directory listings under ANDA 204633
Product	Strength	Form · route	Labeler	Product NDC
Acitretin	Acitretin 10 mg/1	CapsuleOral	AvKARE	42291-086
Acitretin	Acitretin 10 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2222
Acitretin	Acitretin 17.5 mg/1	CapsuleOral	Sigmapharm Laboratories, LLC	42794-081
Acitretin	Acitretin 25 mg/1	CapsuleOral	Sigmapharm Laboratories, LLC	42794-083
Acitretin	Acitretin 17.5 mg/1	CapsuleOral	AvKARE	42291-087
Acitretin	Acitretin 25 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2223
Acitretin	Acitretin 25 mg/1	CapsuleOral	AvKARE	42291-088
Acitretin	Acitretin 17.5 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2224