NDC 70788-580

Regen

5% Minoxidil Topical Solution

Regen is a Topical Solution in the Human Otc Drug category. It is labeled and distributed by Premium Distribution, Llc. The primary component is Minoxidil.

• Product ID: 70788-580_ab7844b9-fc1f-40da-9992-2c6eda824ee3
• NDC: 70788-580
• Product Type: Human Otc Drug
• Proprietary Name: Regen
• Generic Name: 5% Minoxidil Topical Solution
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-12-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076239
• Labeler Name: Premium Distribution, LLC
• Substance Name: MINOXIDIL
• Active Ingredient Strength: 50 mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70788-580-01

1 BOTTLE, PLASTIC in 1 CARTON (70788-580-01) > 60 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2016-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70788-580-01 [70788058001]

Regen SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA076239
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-12-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MINOXIDIL	50 mg/mL

OpenFDA Data

• SPL SET ID: bffed457-967a-4afb-87c9-3e4e1285f04d
• Manufacturer:
  • Premium Distribution, LLC
• UNII:
  • 5965120SH1
• RxNorm Concept Unique ID - RxCUI:
  • 311724

NDC Crossover Matching brand name "Regen" or generic name "5% Minoxidil Topical Solution"

NDC	Brand Name	Generic Name
44911-0272	Regen	Cinnamomum, Echinacea (Angustifolia), Hydrastis Canadensis, Lappa Major, Trifolium Pratense
44911-0529	Regen	Cinnamomum, Echinacea (Angustifolia), Hydrastis Canadensis, Lappa Major, Trifolium Pratense
70788-580	Regen	5% Minoxidil Topical Solution
54111-205	Hair Regrow	5% Minoxidil Topical Solution