Prescription drug · ANDA
Adapalene and benzoyl peroxide NDC 72578-119
Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g · Gel · Topical · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-119-02 | 7257801190272578011902 | 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-02) / 60 g in 1 BOTTLE, PUMPMarketed from Jun 6, 2022 | |
| 72578-119-04 | 7257801190472578011904 | 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-04) / 45 g in 1 BOTTLE, PUMPMarketed from Jun 6, 2022 |
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)
- Adapalene and benzoyl peroxide
- Generic name (nonproprietary)
- adapalene and benzoyl peroxide
- Active ingredients
- Adapalene — 3 mg/gBenzoyl peroxide — 25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Viona Pharmaceuticals IncNDC labeler code 72578
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214553
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 72578-119_edefb257-b872-45cb-a882-fa6991d6cb57SPL ID edefb257-b872-45cb-a882-fa6991d6cb57SPL set ID 3a0fa489-4720-4760-a476-2317aef5a231RxCUI 1663745UNII 1L4806J2QF, W9WZN9A0GM
- 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
N472578011902followed by a unit qualifier and the quantityPackage 72578-0119-02. 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 .
Indications (excerpt from the label)
Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and benzoyl peroxide gel, is a combination of adapalene, a retinoid and benzoyl peroxide and is 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.
About NDC 72578-119
- What is NDC 72578-119?
- 72578-119 is the product NDC for Adapalene and benzoyl peroxide, Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g gel, 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?
- Adapalene and benzoyl peroxide.
- What is the active ingredient?
- Adapalene, Benzoyl peroxide.
- 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 Adapalene and benzoyl peroxide?
- 15 other product NDCs are listed under this name. See all Adapalene and benzoyl peroxide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adapalene and benzoyl peroxide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adapalene and benzoyl peroxide | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Aurobindo Pharma Limited | 59651-604 | 59651-0604-4659651-0604-60 |
| Adapalene And Benzoyl Peroxideadapalene and benzoyl peroxide topical | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Alembic Pharmaceuticals Limited | 46708-662 | 46708-0662-45 |
| Adapalene and benzoyl peroxide | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Teva Pharmaceuticals, Inc. | 0480-3154 | 00480-3154-45 |
| Adapalene And Benzoyl Peroxideadapalene and benzoyl peroxide topical | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Alembic Pharmaceuticals Inc. | 62332-662 | 62332-0662-45 |
| Adapalene and benzoyl peroxide | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Zydus Lifesciences Limited | 70771-1716 | 70771-1716-0370771-1716-04 |
| Adapalene And Benzoyl Peroxide | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-853 | 45802-0853-45 |
| Adapalene And Benzoyl Peroxide | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Bryant Ranch Prepack | 63629-9322 | 63629-9322-01 |
| Adapalene And Benzoyl Peroxide | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Bryant Ranch Prepack | 72162-1432 | 72162-1432-02 |
| adapalene and benzoyl peroxide | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Mayne Pharma Inc. | 68308-662 | 68308-0662-45 |
| adapalene and benzoyl peroxide | Adapalene 1 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Glenmark Pharmaceuticals Inc., USA | 68462-301 | 68462-0301-4768462-0301-55 |
Other NDCs under ANDA 214553
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 |
|---|---|---|---|---|
| Adapalene and benzoyl peroxide | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Zydus Lifesciences Limited | 70771-1716 |