What is NDC 21922-043?

21922-043 is the product NDC for Tretinoin, Tretinoin .8 mg/g gel, listed with the FDA by Encube Ethicals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Encube Ethicals, Inc., NDC labeler code 21922. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tretinoin?

68 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tretinoin NDC 21922-043 | National Drug Code

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	2192200434021922004340	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.NDC labeler code 21922
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)

About NDC 21922-043

What is NDC 21922-043?: 21922-043 is the product NDC for Tretinoin, Tretinoin .8 mg/g gel, listed with the FDA by Encube Ethicals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tretinoin.
What is the active ingredient?: Tretinoin.
Who is the labeler?: Encube Ethicals, Inc., NDC labeler code 21922. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tretinoin?: 68 other product NDCs are listed under this name. See all Tretinoin 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 Tretinoin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tretinoin	Tretinoin .25 mg/g	CreamTopical	Zydus Lifesciences Limited	70771-1933	70771-1933-0270771-1933-04
Tretinoin	Tretinoin .25 mg/g	CreamTopical	Viona Pharmaceuticals Inc	72578-155	72578-0155-0872578-0155-09
Tretinoin	Tretinoin .5 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-808	46708-0808-0046708-0808-20
Tretinoin	Tretinoin .5 mg/g	CreamTopical	Alembic Pharmaceuticals Inc.	62332-808	62332-0808-2062332-0808-45
Tretinoin	Tretinoin .8 mg/g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2323	69238-2323-01
Tretinoin	Tretinoin .6 mg/g	GelTopical	Encube Ethicals, Inc.	21922-042	21922-0042-40
Tretinoin	Tretinoin .5 mg/g	CreamTopical	Encube Ethicals, Inc.	21922-078	21922-0078-0621922-0078-25
Tretinoin	Tretinoin 1 mg/g	CreamTopical	Encube Ethicals, Inc.	21922-077	21922-0077-0621922-0077-25
Tretinoin	Tretinoin .25 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-4069	68788-4069-02
Tretinoin	Tretinoin .25 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-809	46708-0809-2046708-0809-45

All 69 Tretinoin NDCs

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	Tretinoin .6 mg/g	GelTopical	Encube Ethicals, Inc.	21922-042
Tretinoin	Tretinoin .8 mg/g	GelTopical	Bryant Ranch Prepack	72162-2303
Tretinoin (Microsphere)tretinoin	Tretinoin .8 mg/g	GelTopical	Mayne Pharma	68308-777