NDC 49908-117

Adapalene Topical Solution

Adapalene Topical Solution

Adapalene Topical Solution is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Call Inc (d.b.a Rochester Pharmaceuticals). The primary component is Adapalene.

• Product ID: 49908-117_3d32addc-f42a-6b9c-e054-00144ff8d46c
• NDC: 49908-117
• Product Type: Human Prescription Drug
• Proprietary Name: Adapalene Topical Solution
• Generic Name: Adapalene Topical Solution
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-10-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203981
• Labeler Name: CALL INC (d.b.a Rochester Pharmaceuticals)
• Substance Name: ADAPALENE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49908-117-70

120 mL in 1 CARTON (49908-117-70)

• Marketing Start Date: 2021-12-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49908-117-60 [49908011760]

Adapalene Topical Solution SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203981
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-10-03
• Marketing End Date: 2020-01-17

Drug Details

Active Ingredients

Ingredient	Strength
ADAPALENE	1 mg/mL

OpenFDA Data

• SPL SET ID: 5c6dde30-07d0-4ff9-a0ff-b7ecf88f2310
• Manufacturer:
  • CALL INC (d.b.a Rochester Pharmaceuticals)
• UNII:
  • 1L4806J2QF
• RxNorm Concept Unique ID - RxCUI:
  • 307732

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]

NDC Crossover Matching brand name "Adapalene Topical Solution" or generic name "Adapalene Topical Solution"

NDC	Brand Name	Generic Name
0682-0053	Adapalene Topical Solution	Adapalene
49908-117	Adapalene Topical Solution	Adapalene Topical Solution
71297-410	Adapalene Topical Solution	Adapalene Topical Solution