Isotretinoin NDC 84386-010

NDC codes

FDA NDC Directory

Product NDC (as listed)84386-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84386-0010Add 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
84386-010-03	84386001003	3 BLISTER PACK in 1 CARTON (84386-010-03) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 10, 2026

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 — 30 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 220336
Marketing start: Sep 10, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 84386-010_9f75ad9f-40e7-4e6a-b722-f4c3e0be3432SPL ID 9f75ad9f-40e7-4e6a-b722-f4c3e0be3432
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

N484386001003 followed by a unit qualifier and the quantity

Package 84386-0010-03. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 220336

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

FDA NDC Directory listings under ANDA 220336
Product	Strength	Form · route	Labeler	Product NDC
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-009
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-011