Tretinoin NDC 0574-2201

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-2201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-2201Add 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
0574-2201-20	00574220120	1 TUBE in 1 CARTON (0574-2201-20) / 20 g in 1 TUBEMarketed from Mar 30, 2017
0574-2201-45	00574220145	1 TUBE in 1 CARTON (0574-2201-45) / 45 g in 1 TUBEMarketed from Apr 17, 2017

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 — 1 mg/g
Dosage form: Cream
Route: Topical
Labeler: Padagis US LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075213
Marketing start: Mar 30, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0574-2201_f7c1542f-286b-449a-86f6-b86f7369c36eSPL ID f7c1542f-286b-449a-86f6-b86f7369c36eSPL set ID 4889c7f8-37d0-4f1a-9829-bca107806586RxCUI 106302, 106303, 198300, 313450, 313451UNII 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

N400574220120 followed by a unit qualifier and the quantity

Package 00574-2201-20. 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 Dec 31, 2023.

Indications (excerpt from the label)

Indications and Usage: Tretinoin gel and cream are 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 ANDA 075213

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

FDA NDC Directory listings under ANDA 075213
Product	Strength	Form · route	Labeler	Product NDC
Tretinoin	Tretinoin 1 mg/g	CreamTopical	REMEDYREPACK INC.	70518-3233