What is NDC 84386-009?

84386-009 is the product NDC for Isotretinoin, Isotretinoin 20 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 84386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Isotretinoin?

66 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isotretinoin NDC 84386-009 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)84386-009Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84386-0009Add 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
84386-009-03	8438600090384386000903	3 BLISTER PACK in 1 CARTON (84386-009-03) / 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 — 20 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 84386
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 84386-009_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

N484386000903 followed by a unit qualifier and the quantity

Package 84386-0009-03. 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.

About NDC 84386-009

What is NDC 84386-009?: 84386-009 is the product NDC for Isotretinoin, Isotretinoin 20 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Isotretinoin.
What is the active ingredient?: Isotretinoin.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 84386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Isotretinoin?: 66 other product NDCs are listed under this name. See all Isotretinoin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Isotretinoin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Isotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-010	84386-0010-03
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-011	84386-0011-03
Isotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1254	69238-1254-03
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1255	69238-1255-03
Isotretinoin	Isotretinoin 25 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1256	69238-1256-03
Isotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1257	69238-1257-03
Isotretinoin	Isotretinoin 35 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1258	69238-1258-03
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1259	69238-1259-03
Isotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1574	70710-1574-08
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1575	70710-1575-08

All 67 Isotretinoin NDCs

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 30 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-010
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-011