Prescription drug · ANDA
Tretinoin NDC 72578-155
Tretinoin .25 mg/g · Cream · Topical · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-155-08 | 72578015508 | 1 TUBE in 1 CARTON (72578-155-08) / 45 g in 1 TUBEMarketed from Oct 1, 2026 | |
| 72578-155-09 | 72578015509 | 1 TUBE in 1 CARTON (72578-155-09) / 20 g in 1 TUBEMarketed from Oct 1, 2026 |
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 — .25 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 218560
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 72578-155_22150db5-d543-419f-bc09-a3280e19777bSPL ID 22150db5-d543-419f-bc09-a3280e19777b
- 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
N472578015508followed by a unit qualifier and the quantityPackage 72578-0155-08. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 72578-155
- What is NDC 72578-155?
- 72578-155 is the product NDC for Tretinoin, Tretinoin .25 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.
Related NDCs: other Tretinoin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 .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 |
| Tretinoin | Tretinoin .25 mg/g | CreamTopical | Alembic Pharmaceuticals Inc. | 62332-809 | 62332-0809-2062332-0809-45 |
Other NDCs under ANDA 218560
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tretinoin | Tretinoin .25 mg/g | CreamTopical | Zydus Lifesciences Limited | 70771-1933 |