Isotretinoin NDC 69238-1175

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1175Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1175Add 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
69238-1175-3	69238117503	3 BLISTER PACK in 1 CARTON (69238-1175-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1175-1)Marketed from Oct 2, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207792
Marketing start: Oct 2, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 69238-1175_9466bc95-3be7-43f8-b0c3-74a7df2d5a67SPL ID 9466bc95-3be7-43f8-b0c3-74a7df2d5a67SPL set ID c2917c3d-3499-48a0-ba53-120cb979195dRxCUI 197843, 197844, 197845, 403930UNII EH28UP18IFUPC 0369238101737, 0369238117431, 0369238117530, 0369238117639
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

N469238117503 followed by a unit qualifier and the quantity

Package 69238-1175-03. 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 Aug 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Isotretinoin Capsules is 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 is 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 two-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.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207792

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

FDA NDC Directory listings under ANDA 207792
Product	Strength	Form · route	Labeler	Product NDC
Isotretinoin	Isotretinoin 30 mg/1	Capsule, Liquid filledOral	Amneal Pharmaceuticals LLC	69238-1017
Isotretinoin	Isotretinoin 40 mg/1	Capsule, Liquid filledOral	Amneal Pharmaceuticals LLC	69238-1176
Isotretinoin	Isotretinoin 10 mg/1	Capsule, Liquid filledOral	Amneal Pharmaceuticals LLC	69238-1174