Prescription drug · ANDA

Zenatane (isotretinoin) NDC 68001-653

Isotretinoin 20 mg/1 · Capsule, Gelatin coated · Oral · BluePoint Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)68001-653Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0653Add 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
68001-653-17680010653173 BLISTER PACK in 1 CARTON (68001-653-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-653-16)Marketed from Dec 24, 2025

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 — 20 mg/1
Dosage form
Capsule, Gelatin coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202099
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 68001-653_4e69c221-c1ba-9b55-e063-6394a90afbd4SPL ID 4e69c221-c1ba-9b55-e063-6394a90afbd4SPL set ID 486d4a4b-0de5-431a-bef7-dae6b0e4fa20RxCUI 197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088UNII EH28UP18IFUPC 0368001655170, 0368001652179, 0368001653176
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

N468001065317 followed by a unit qualifier and the quantity

Package 68001-0653-17. 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 . 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
ProductStrengthForm · routeLabelerProduct NDC
ZenataneisotretinoinIsotretinoin 30 mg/1Capsule, Gelatin coatedOralDr. Reddy's Laboratories Limited55111-113
ZenataneisotretinoinIsotretinoin 20 mg/1Capsule, Gelatin coatedOralDr. Reddy's Laboratories Limited55111-136
ZenataneisotretinoinIsotretinoin 10 mg/1Capsule, Gelatin coatedOralDr. Reddy's Laboratories Limited55111-135
ZenataneisotretinoinIsotretinoin 40 mg/1Capsule, Gelatin coatedOralDr. Reddy's Laboratories Limited55111-137
AccutaneisotretinoinIsotretinoin 20 mg/1Capsule, Gelatin coatedOralJG Pharma Inc.72143-252
AccutaneisotretinoinIsotretinoin 10 mg/1Capsule, Gelatin coatedOralJG Pharma Inc.72143-251
AccutaneisotretinoinIsotretinoin 30 mg/1Capsule, Gelatin coatedOralJG Pharma Inc.72143-253
AccutaneisotretinoinIsotretinoin 40 mg/1Capsule, Gelatin coatedOralJG Pharma Inc.72143-254
ZenataneisotretinoinIsotretinoin 40 mg/1Capsule, Gelatin coatedOralBluePoint Laboratories68001-655
ZenataneisotretinoinIsotretinoin 10 mg/1Capsule, Gelatin coatedOralBluePoint Laboratories68001-652
ZenataneisotretinoinIsotretinoin 30 mg/1Capsule, Gelatin coatedOralBluePoint Laboratories68001-654

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Zenatane (isotretinoin) NDC 68001-653 | Med-Code