Zenatane (isotretinoin) NDC 55111-137

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-137Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0137Add 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
55111-137-81	55111013781	3 BLISTER PACK in 1 CARTON (55111-137-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-137-79)Marketed from Mar 26, 2013

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): Zenatane
Generic name (nonproprietary): isotretinoin
Active ingredients: Isotretinoin — 40 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202099
Marketing start: Mar 26, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 55111-137_d7d883f9-7d20-2c50-8023-e661b46dcd5bSPL ID d7d883f9-7d20-2c50-8023-e661b46dcd5bSPL set ID 27b3cf26-f22e-5b70-1c24-009933b7c6eeRxCUI 197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088UNII EH28UP18IF
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

N455111013781 followed by a unit qualifier and the quantity

Package 55111-0137-81. 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 Feb 7, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see Boxed CONTRAINDI…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202099

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

FDA NDC Directory listings under ANDA 202099
Product	Strength	Form · route	Labeler	Product NDC
Zenataneisotretinoin	Isotretinoin 30 mg/1	Capsule, Gelatin coatedOral	Dr. Reddy's Laboratories Limited	55111-113
Zenataneisotretinoin	Isotretinoin 20 mg/1	Capsule, Gelatin coatedOral	Dr. Reddy's Laboratories Limited	55111-136
Zenataneisotretinoin	Isotretinoin 10 mg/1	Capsule, Gelatin coatedOral	Dr. Reddy's Laboratories Limited	55111-135
Accutaneisotretinoin	Isotretinoin 20 mg/1	Capsule, Gelatin coatedOral	JG Pharma Inc.	72143-252
Accutaneisotretinoin	Isotretinoin 10 mg/1	Capsule, Gelatin coatedOral	JG Pharma Inc.	72143-251
Accutaneisotretinoin	Isotretinoin 30 mg/1	Capsule, Gelatin coatedOral	JG Pharma Inc.	72143-253
Accutaneisotretinoin	Isotretinoin 40 mg/1	Capsule, Gelatin coatedOral	JG Pharma Inc.	72143-254
Zenataneisotretinoin	Isotretinoin 40 mg/1	Capsule, Gelatin coatedOral	BluePoint Laboratories	68001-655
Zenataneisotretinoin	Isotretinoin 10 mg/1	Capsule, Gelatin coatedOral	BluePoint Laboratories	68001-652
Zenataneisotretinoin	Isotretinoin 20 mg/1	Capsule, Gelatin coatedOral	BluePoint Laboratories	68001-653
Zenataneisotretinoin	Isotretinoin 30 mg/1	Capsule, Gelatin coatedOral	BluePoint Laboratories	68001-654