What is NDC 57664-023?

57664-023 is the product NDC for Isotretinoin, Isotretinoin 30 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. 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 57664-023 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57664-023Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57664-0023Add 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
57664-023-97	5766400239757664002397	3 BLISTER PACK in 1 BOX (57664-023-97) / 10 CAPSULE in 1 BLISTER PACK (57664-023-98)Marketed from Dec 29, 2020

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: Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021951
Marketing start: Dec 29, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 57664-023_0e924cf6-5375-28c4-e063-6294a90a4ac4SPL ID 0e924cf6-5375-28c4-e063-6294a90a4ac4SPL set ID b44200ba-6672-4ea7-b151-7caec3f53c9cRxCUI 197843, 197844, 197845, 403930, 1547561, 1547565UNII 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

N457664002397 followed by a unit qualifier and the quantity

Package 57664-0023-97. 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 Jan 10, 2024. 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. Limitations of Use : If a second course of isotretinoin capsules therapy 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 therapy [see Dosage and Administration (2.2)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57664-023

What is NDC 57664-023?: 57664-023 is the product NDC for Isotretinoin, Isotretinoin 30 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. 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 NDA 021951

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

FDA NDC Directory listings under NDA 021951
Product	Strength	Form · route	Labeler	Product NDC
Absoricaisotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-115
Absoricaisotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-116
Absoricaisotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-117
Absoricaisotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-118
Absoricaisotretinoin	Isotretinoin 25 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-133
Absoricaisotretinoin	Isotretinoin 35 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	10631-134
Isotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-020
Isotretinoin	Isotretinoin 20 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-021
Isotretinoin	Isotretinoin 25 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-022
Isotretinoin	Isotretinoin 35 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-024
Isotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	57664-025