NDC 63629-5637

Trezix

Acetaminophen, Caffeine, Dihydrocodeine Bitartrate

Trezix is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Acetaminophen; Caffeine; Dihydrocodeine Bitartrate.

• Product ID: 63629-5637_0f379aba-f28b-40b4-a2fc-d807829f2c70
• NDC: 63629-5637
• Product Type: Human Prescription Drug
• Proprietary Name: Trezix
• Generic Name: Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-12-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204785
• Labeler Name: Bryant Ranch Prepack
• Substance Name: ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
• Active Ingredient Strength: 321 mg/1; mg/1; mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63629-5637-1

30 CAPSULE in 1 BOTTLE (63629-5637-1)

• Marketing Start Date: 2015-06-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63629-5637-4 [63629563704]

Trezix CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204785
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-26
• Inactivation Date: 2020-01-31

NDC 63629-5637-1 [63629563701]

Trezix CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204785
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-06-04
• Inactivation Date: 2020-01-31

NDC 63629-5637-2 [63629563702]

Trezix CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204785
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-06-04
• Inactivation Date: 2020-01-31

NDC 63629-5637-3 [63629563703]

Trezix CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204785
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-13
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	320.5 mg/1

OpenFDA Data

• SPL SET ID: f90f87cb-77ad-45f4-8b59-09459090d988
• Manufacturer:
  • Bryant Ranch Prepack
• UNII:
  • 8LXS95BSA9
  • 362O9ITL9D
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 1190201
  • 1596108

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]

NDC Crossover Matching brand name "Trezix" or generic name "Acetaminophen, Caffeine, Dihydrocodeine Bitartrate"

NDC	Brand Name	Generic Name
63187-705	Trezix	acetaminophen, caffeine, dihydrocodeine bitartrate
63629-5637	Trezix	acetaminophen, caffeine, dihydrocodeine bitartrate
66992-340	Trezix	acetaminophen, caffeine, dihydrocodeine bitartrate
66992-840	Trezix	acetaminophen, caffeine, dihydrocodeine bitartrate
42195-840	Acetaminophen, Caffeine, Dihydrocodeine Bitartrate	Acetaminophen, Caffeine, Dihydrocodeine Bitartrate