NDC 70569-152

DVORAH

Acetaminophen, Caffeine And Dihydrocodeine Bitartrate

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

• Product ID: 70569-152_7cfdc4a6-8f54-4a3a-e053-2991aa0a661b
• NDC: 70569-152
• Product Type: Human Prescription Drug
• Proprietary Name: DVORAH
• Generic Name: Acetaminophen, Caffeine And Dihydrocodeine Bitartrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-12-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204209
• Labeler Name: Phlight Pharma, LLC
• Substance Name: ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
• Active Ingredient Strength: 325 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 70569-152-30

30 TABLET in 1 BOTTLE (70569-152-30)

• Marketing Start Date: 2018-12-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70569-152-01 [70569015201]

DVORAH TABLET

• Marketing Category: ANDA
• Application Number: ANDA204209
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-12-06

NDC 70569-152-30 [70569015230]

DVORAH TABLET

• Marketing Category: ANDA
• Application Number: ANDA204209
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-06

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: ae506864-1688-4aa2-8f70-6d03ebdebabf
• Manufacturer:
  • Phlight Pharma, LLC
• UNII:
  • 8LXS95BSA9
  • 362O9ITL9D
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 1812164
  • 2105929

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
70362-730	DVORAH	acetaminophen, caffeine and dihydrocodeine bitartrate
70569-152	DVORAH	acetaminophen, caffeine and dihydrocodeine bitartrate
68047-720	Acetaminophen, Caffeine and Dihydrocodeine Bitartrate	Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
71993-300	Acetaminophen, Caffeine and Dihydrocodeine Bitartrate	Acetaminophen, Caffeine and Dihydrocodeine Bitartrate