What is NDC 0378-7020?

0378-7020 is the product NDC for Acitretin, Acitretin 10 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acitretin?

21 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acitretin NDC 0378-7020 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7020Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7020Add 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
0378-7020-93	00378702093	30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7020-93)Marketed from Mar 10, 2016

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): Acitretin
Generic name (nonproprietary): acitretin
Active ingredients: Acitretin — 10 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202148
Marketing start: Mar 10, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0378-7020_4e629ef9-879a-443d-9397-c47962855dd8SPL ID 4e629ef9-879a-443d-9397-c47962855dd8SPL set ID 2150bb0f-551b-4059-a97b-187d3ab22519RxCUI 199689, 199690UNII LCH760E9T7
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

N400378702093 followed by a unit qualifier and the quantity

Package 00378-7020-93. 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 Dec 20, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS - Acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-7020

What is NDC 0378-7020?: 0378-7020 is the product NDC for Acitretin, Acitretin 10 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acitretin.
What is the active ingredient?: Acitretin.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acitretin?: 21 other product NDCs are listed under this name. See all Acitretin 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 Acitretin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acitretin	Acitretin 10 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-741	46708-0741-30
Acitretin	Acitretin 17.5 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-742	46708-0742-30
Acitretin	Acitretin 25 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-743	46708-0743-30
Acitretin	Acitretin 10 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-741	62332-0741-30
Acitretin	Acitretin 17.5 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-742	62332-0742-30
Acitretin	Acitretin 25 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-743	62332-0743-30
Acitretin	Acitretin 10 mg/1	CapsuleOral	AvKARE	42291-086	42291-0086-30
Acitretin	Acitretin 17.5 mg/1	CapsuleOral	AvKARE	42291-087	42291-0087-30
Acitretin	Acitretin 25 mg/1	CapsuleOral	AvKARE	42291-088	42291-0088-30
Acitretin	Acitretin 25 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-7023	00378-7023-93

All 22 Acitretin NDCs

Other NDCs under ANDA 202148

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

FDA NDC Directory listings under ANDA 202148
Product	Strength	Form · route	Labeler	Product NDC
Acitretin	Acitretin 25 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-7023