NDC 42195-840

Acetaminophen, Caffeine, Dihydrocodeine Bitartrate

Acetaminophen, Caffeine, Dihydrocodeine Bitartrate

Acetaminophen, Caffeine, Dihydrocodeine Bitartrate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Xspire Pharma Llc. The primary component is Acetaminophen; Caffeine; Dihydrocodeine Bitartrate.

• Product ID: 42195-840_724970d8-1756-4eb8-8a1e-e3dc9d9895f9
• NDC: 42195-840
• Product Type: Human Prescription Drug
• Proprietary Name: Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
• Generic Name: Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204785
• Labeler Name: XSPIRE PHARMA LLC
• Substance Name: ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
• Active Ingredient Strength: 321 mg/1; mg/1; mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 42195-840-10

100 CAPSULE in 1 BOTTLE (42195-840-10)

• Marketing Start Date: 2015-08-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42195-840-10 [42195084010]

Acetaminophen, Caffeine, Dihydrocodeine Bitartrate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204785
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-08-05

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	320.5 mg/1

OpenFDA Data

• SPL SET ID: 76e033b0-01c1-42df-bb64-f8ca401cfb6b
• Manufacturer:
  • XSPIRE PHARMA LLC
• UNII:
  • 8LXS95BSA9
  • 362O9ITL9D
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 1596108
• UPC Code:
  • 0342195840109

Pharmacological Class

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

Medicade Reported Pricing

42195084010 DIHYDROCODEIN-ACETAMINOPH-CAFF

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
42195-840	Acetaminophen, Caffeine, Dihydrocodeine Bitartrate	Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
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