Amnesteem (isotretinoin) NDC 0378-6612

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-6612Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-6612Add 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
0378-6612-93	00378661293	3 BLISTER PACK in 1 CARTON (0378-6612-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6612-85)Marketed from Nov 11, 2002

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Amnesteem
Generic name (nonproprietary): isotretinoin
Active ingredients: Isotretinoin — 20 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075945
Marketing start: Nov 11, 2002
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0378-6612_4e5dc880-a474-43c1-b126-9cce9e6d066fSPL ID 4e5dc880-a474-43c1-b126-9cce9e6d066fSPL set ID b2cb63c9-f825-4991-9a2c-6260f1bbcc2cRxCUI 197843, 197844, 197845, 403930, 404058, 404061, 404064, 2711694UNII 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

N400378661293 followed by a unit qualifier and the quantity

Package 00378-6612-93. 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 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Amnesteem 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, Amnesteem 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 Amnesteem 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 (2.2) ]. Amnesteem is a retinoid indica…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075945

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

FDA NDC Directory listings under ANDA 075945
Product	Strength	Form · route	Labeler	Product NDC
Amnesteemisotretinoin	Isotretinoin 30 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-6613
Amnesteemisotretinoin	Isotretinoin 40 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-6614
Amnesteemisotretinoin	Isotretinoin 10 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-6611