NDC 61919-412

OXYCODONE APAP

Oxycodone Apap

OXYCODONE APAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Oxycodone Hydrochloride; Acetaminophen.

• Product ID: 61919-412_6764cf5d-5320-6063-e053-2a91aa0a2409
• NDC: 61919-412
• Product Type: Human Prescription Drug
• Proprietary Name: OXYCODONE APAP
• Generic Name: Oxycodone Apap
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-03-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201972
• Labeler Name: DIRECT RX
• Substance Name: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
• Active Ingredient Strength: 8 mg/1; mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 61919-412-30

30 TABLET in 1 BOTTLE (61919-412-30)

• Marketing Start Date: 2018-03-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-412-30 [61919041230]

OXYCODONE APAP TABLET

• Marketing Category: ANDA
• Application Number: ANDA201972
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-03-14

Drug Details

Active Ingredients

Ingredient	Strength
OXYCODONE HYDROCHLORIDE	7.5 mg/1

OpenFDA Data

• SPL SET ID: 2c8539a3-2557-56f2-e054-00144ff8d46c
• Manufacturer:
  • DIRECT RX
• UNII:
  • 362O9ITL9D
  • C1ENJ2TE6C
• RxNorm Concept Unique ID - RxCUI:
  • 1049225

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "OXYCODONE APAP" or generic name "Oxycodone Apap"

NDC	Brand Name	Generic Name
61919-412	OXYCODONE APAP	OXYCODONE APAP
61919-615	OXYCODONE APAP	OXYCODONE APAP