What is NDC 59651-633?

59651-633 is the product NDC for Isotretinoin, Isotretinoin 25 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 59651. 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 59651-633 | National Drug Code

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	5965106330359651063303	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 LimitedNDC labeler code 59651
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_4f6cfc86-c6ad-413a-baf6-5df2b0cb3511SPL ID 4f6cfc86-c6ad-413a-baf6-5df2b0cb3511
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

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

About NDC 59651-633

What is NDC 59651-633?: 59651-633 is the product NDC for Isotretinoin, Isotretinoin 25 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 59651. 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 20 mg/1	CapsuleOral	Aurobindo Pharma Limited	84386-009	84386-0009-03
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

All 67 Isotretinoin NDCs

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 10 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-631
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-632
Isotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-634
Isotretinoin	Isotretinoin 35 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-635
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-636