Tretinoin NDC 21922-043

NDC codes

FDA NDC Directory

Product NDC (as listed)21922-043Labeler and product segments. Claims need a package NDC.

Product NDC at billing width21922-0043Add 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
21922-043-40	21922004340	1 BOTTLE, PUMP in 1 CARTON (21922-043-40) / 50 g in 1 BOTTLE, PUMPMarketed from Aug 24, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .8 mg/g
Dosage form: Gel
Route: Topical
Labeler: Encube Ethicals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215609
Marketing start: Aug 24, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 21922-043_8cc4690a-be86-4f4a-8bd1-ff9f5d5d5747SPL ID 8cc4690a-be86-4f4a-8bd1-ff9f5d5d5747SPL set ID 57558405-42fa-40bb-a61c-48e030d976deRxCUI 1488045, 1987644UNII 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

N421922004340 followed by a unit qualifier and the quantity

Package 21922-0043-40. 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 Apr 16, 2026.

Indications (excerpt from the label)

Tretinoin gel (microsphere) is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Tretinoin gel (microsphere) is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215609

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

FDA NDC Directory listings under ANDA 215609
Product	Strength	Form · route	Labeler	Product NDC
Tretinoin (Microsphere)tretinoin	Tretinoin .8 mg/g	GelTopical	Mayne Pharma	68308-777
Tretinoin	Tretinoin .8 mg/g	GelTopical	Bryant Ranch Prepack	72162-2303
Tretinoin	Tretinoin .6 mg/g	GelTopical	Encube Ethicals, Inc.	21922-042