Isotretinoin NDC 68308-575

NDC codes

FDA NDC Directory

Product NDC (as listed)68308-575Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68308-0575Add 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
68308-575-30	68308057530	3 BLISTER PACK in 1 BOX (68308-575-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01)Marketed from Sep 3, 2021

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 — 40 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Mayne Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213571
Marketing start: Sep 3, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 68308-575_52056651-f1ce-4586-9c28-f919591060a4SPL ID 52056651-f1ce-4586-9c28-f919591060a4SPL set ID 72867c88-070f-4608-bfef-cc5225ebce6dRxCUI 197845UNII 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

N468308057530 followed by a unit qualifier and the quantity

Package 68308-0575-30. 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 Nov 3, 2022. 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. Isotretinoin capsules are retinoids 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 associat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213571

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

FDA NDC Directory listings under ANDA 213571
Product	Strength	Form · route	Labeler	Product NDC
Isotretinoin	Isotretinoin 40 mg/1	Capsule, Liquid filledOral	Upsher-Smith Laboratories, LLC	0245-0575