Prescription drug · ANDA
Adapalene and benzoyl peroxide NDC 70771-1716
Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g · Gel · Topical · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1716-3 | 7077117160370771171603 | 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-3) / 60 g in 1 BOTTLE, PUMPMarketed from Jun 6, 2022 | |
| 70771-1716-4 | 7077117160470771171604 | 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-4) / 45 g in 1 BOTTLE, PUMPMarketed from Jun 6, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Zydus Lifesciences LimitedNDC labeler code 70771
- 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 70771-1716_2825a88e-4c88-4703-9128-ad478f3aae28SPL ID 2825a88e-4c88-4703-9128-ad478f3aae28SPL set ID d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5RxCUI 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
N470771171603followed by a unit qualifier and the quantityPackage 70771-1716-03. 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 .
About NDC 70771-1716
- What is NDC 70771-1716?
- 70771-1716 is the product NDC for Adapalene and benzoyl peroxide, Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g gel, listed with the FDA by Zydus Lifesciences Limited. 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 | Viona Pharmaceuticals Inc | 72578-119 | 72578-0119-0272578-0119-04 |
| 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 | Viona Pharmaceuticals Inc | 72578-119 |