NDC 66992-955

Phrenilin Forte

Butalbital, Acetaminophen, Caffeine

Phrenilin Forte is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Wraser Llc. The primary component is Butalbital; Acetaminophen; Caffeine.

• Product ID: 66992-955_109b9af7-e798-46d3-997c-5df01c73212b
• NDC: 66992-955
• Product Type: Human Prescription Drug
• Proprietary Name: Phrenilin Forte
• Generic Name: Butalbital, Acetaminophen, Caffeine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-09-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206615
• Labeler Name: Wraser LLC
• Substance Name: BUTALBITAL; ACETAMINOPHEN; CAFFEINE
• Active Ingredient Strength: 50 mg/1; mg/1; mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Barbiturates [CS],Barbiturate [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 66992-955-10

100 CAPSULE in 1 BOTTLE (66992-955-10)

• Marketing Start Date: 2017-09-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66992-955-10 [66992095510]

Phrenilin Forte CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA206615
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-18
• Marketing End Date: 2019-10-22

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: d8f3608b-814d-4f73-a64a-f60f59231a55
• Manufacturer:
  • Wraser LLC
• UNII:
  • KHS0AZ4JVK
  • 362O9ITL9D
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 1945479
  • 889520
• UPC Code:
  • 0366992955101

Pharmacological Class

• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]
• Barbiturates [CS]
• Barbiturate [EPC]