Prescription drug · ANDA
Zenatane (Isotretinoin) NDC 68001-655
Isotretinoin 40 mg/1 · Capsule, Gelatin coated · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-655-17 | 6800106551768001065517 | 3 BLISTER PACK in 1 CARTON (68001-655-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-655-16)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 — 40 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- 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 68001-655_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
N468001065517followed by a unit qualifier and the quantityPackage 68001-0655-17. 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.
About NDC 68001-655
- What is NDC 68001-655?
- 68001-655 is the product NDC for Zenatane (isotretinoin), Isotretinoin 40 mg/1 capsule, gelatin coated, listed with the FDA by BluePoint Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zenatane (Isotretinoin).
- What is the active ingredient?
- Isotretinoin.
- Who is the labeler?
- BluePoint Laboratories, NDC labeler code 68001. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zenatane?
- 7 other product NDCs are listed under this name. See all Zenatane NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zenatane products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zenataneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-652 | 68001-0652-17 |
| Zenataneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-653 | 68001-0653-17 |
| Zenataneisotretinoin | Isotretinoin 30 mg/1 | Capsule, Gelatin coatedOral | BluePoint Laboratories | 68001-654 | 68001-0654-17 |
| Zenataneisotretinoin | Isotretinoin 30 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-113 | 55111-0113-7855111-0113-81 |
| Zenataneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-135 | 55111-0135-81 |
| Zenataneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-136 | 55111-0136-81 |
| Zenataneisotretinoin | Isotretinoin 40 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-137 | 55111-0137-81 |
Other NDCs under ANDA 202099
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Accutaneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | JG Pharma Inc. | 72143-251 |
| Accutaneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | JG Pharma Inc. | 72143-252 |
| 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 30 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-113 |
| Zenataneisotretinoin | Isotretinoin 10 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-135 |
| Zenataneisotretinoin | Isotretinoin 20 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-136 |
| Zenataneisotretinoin | Isotretinoin 40 mg/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Limited | 55111-137 |
| 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 |