Prescription drug · NDA
epiduo forte NDC 0299-5906
adapalene and benzoyl peroxide · Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g · Gel · Topical · Galderma Laboratories, L.P.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0299-5906-00 | 00299590600 | 2 g in 1 TUBE (0299-5906-00)Marketed from Nov 1, 2019 · Sample package | |
| 0299-5906-02 | 00299590602 | 1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBEMarketed from Jul 1, 2015 · Sample package | |
| 0299-5906-05 | 00299590605 | 1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBEMarketed from Jul 1, 2015 · Sample package | |
| 0299-5906-15 | 00299590615 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMPMarketed from Jul 1, 2015 | |
| 0299-5906-30 | 00299590630 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-30) / 30 g in 1 BOTTLE, PUMPMarketed from Jul 1, 2015 | |
| 0299-5906-45 | 00299590645 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-45) / 45 g in 1 BOTTLE, PUMPMarketed from Jul 1, 2015 | |
| 0299-5906-60 | 00299590660 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-60) / 60 g in 1 BOTTLE, PUMPMarketed from Jul 1, 2015 | |
| 0299-5906-70 | 00299590670 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-70) / 70 g in 1 BOTTLE, PUMPMarketed from Jul 1, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- epiduo forte
- Generic name (nonproprietary)
- adapalene and benzoyl peroxide
- Active ingredients
- Adapalene — 3 mg/gBenzoyl peroxide — 25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Galderma Laboratories, L.P.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207917
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0299-5906_253bb988-14bf-4654-e063-6394a90a0fe0SPL ID 253bb988-14bf-4654-e063-6394a90a0fe0SPL set ID f4e5d381-098a-4c93-9ff0-002cae46daacRxCUI 1663745, 1663747UNII 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
N400299590600followed by a unit qualifier and the quantityPackage 00299-5906-00. 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)
EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. EPIDUO FORTE, 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.
Other NDCs under NDA 207917
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 | Mayne Pharma Inc. | 68308-662 |