Tretinoin NDC 0378-8083

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8083Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8083Add 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
0378-8083-20	00378808320	1 TUBE in 1 CARTON (0378-8083-20) / 20 g in 1 TUBEMarketed from Jul 12, 2019
0378-8083-45	00378808345	1 TUBE in 1 CARTON (0378-8083-45) / 45 g in 1 TUBEMarketed from Dec 17, 2018

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): Tretinoin
Generic name (nonproprietary): tretinoin
Active ingredients: Tretinoin — .5 mg/g
Dosage form: Cream
Route: Topical
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 017522
Marketing start: Nov 5, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0378-8083_96edaee2-b74e-4f7b-947f-1addc75402eaSPL ID 96edaee2-b74e-4f7b-947f-1addc75402eaSPL set ID ba377a5e-e48a-4bd9-9d76-929d70793396RxCUI 106302, 106303, 198300, 313450, 313451UNII 5688UTC01RUPC 0303788082450, 0303788083457, 0303788086151
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378808320 followed by a unit qualifier and the quantity

Package 00378-8083-20. 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 Oct 9, 2024.

Indications (excerpt from the label)

Indications and Usage Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017522

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

FDA NDC Directory listings under NDA 017522
Product	Strength	Form · route	Labeler	Product NDC
Retin-Atretinoin	Tretinoin .5 mg/g	CreamTopical	Bausch Health US, LLC	0187-5162
Tretinoin Creamtretinoin	Tretinoin .5 mg/g	CreamTopical	Obagi Cosmeceuticals LLC	62032-412