Tretinoin NDC 0378-8090

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8090Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8090Add 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
0378-8090-45	00378809045	1 TUBE in 1 CARTON (0378-8090-45) / 45 g in 1 TUBEMarketed from Nov 14, 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: Gel
Route: Topical
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207955
Marketing start: Nov 14, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0378-8090_7f967c10-776a-4b9c-aeda-70276ff2747fSPL ID 7f967c10-776a-4b9c-aeda-70276ff2747fSPL set ID ce5f4f14-5e60-4cc1-bcb3-1fa9b8aa9cd5RxCUI 245723UNII 5688UTC01R
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

N400378809045 followed by a unit qualifier and the quantity

Package 00378-8090-45. 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 Jul 25, 2022.

Indications (excerpt from the label)

Tretinoin gel is indicated for topical treatment of acne vulgaris. Tretinoin gel is a retinoid indicated for topical treatment of acne vulgaris ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)