What is NDC 72578-153?

72578-153 is the product NDC for Tretinoin, Tretinoin 1 mg/g cream, listed with the FDA by Viona Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. 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 72578-153 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-153Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0153Add 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
72578-153-08	7257801530872578015308	1 TUBE in 1 CARTON (72578-153-08) / 45 g in 1 TUBEMarketed from Apr 30, 2024
72578-153-09	7257801530972578015309	1 TUBE in 1 CARTON (72578-153-09) / 20 g in 1 TUBEMarketed from Apr 30, 2024

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 — 1 mg/g
Dosage form: Cream
Route: Topical
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218561
Marketing start: Apr 30, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 72578-153_97ba2e16-fc52-495e-bc88-84f93170ca07SPL ID 97ba2e16-fc52-495e-bc88-84f93170ca07SPL set ID 2ee7844c-e5ee-4d15-80c7-c07a9f23ccddRxCUI 198300UNII 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

N472578015308 followed by a unit qualifier and the quantity

Package 72578-0153-08. 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 26, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tretinoin cream 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)

About NDC 72578-153

What is NDC 72578-153?: 72578-153 is the product NDC for Tretinoin, Tretinoin 1 mg/g cream, listed with the FDA by Viona Pharmaceuticals Inc. It has 2 package NDCs, 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?: Viona Pharmaceuticals Inc, NDC labeler code 72578. 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 218561

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

FDA NDC Directory listings under ANDA 218561
Product	Strength	Form · route	Labeler	Product NDC
Tretinoin	Tretinoin 1 mg/g	CreamTopical	Zydus Lifesciences Limited	70771-1873