Isotretinoin NDC 59651-633

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-633Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0633Add 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
59651-633-03	59651063303	3 BLISTER PACK in 1 CARTON (59651-633-03) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jan 29, 2024

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): Isotretinoin
Generic name (nonproprietary): isotretinoin
Active ingredients: Isotretinoin — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218194
Marketing start: Jan 29, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 59651-633_d7966cd2-9b7b-4a4e-bbcf-4be07461df60SPL ID d7966cd2-9b7b-4a4e-bbcf-4be07461df60SPL set ID 4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6RxCUI 197843, 197844, 197845, 403930, 1547561, 1547565UNII 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

N459651063303 followed by a unit qualifier and the quantity

Package 59651-0633-03. 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 Sep 7, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use If a second course of isotretinoin capsules treatment is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218194

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

FDA NDC Directory listings under ANDA 218194
Product	Strength	Form · route	Labeler	Product NDC
Isotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-634
Isotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-631
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-632
Isotretinoin	Isotretinoin 35 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-635
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-636