NDC 65084-453

Hydrocodone Bitatrate and Acetaminophen

Hydrocodone Bitatrate And Acetaminophen

Hydrocodone Bitatrate and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mckesson Rxpak Inc. The primary component is Hydrocodone Bitartrate; Acetaminophen.

• Product ID: 65084-453_1aee5ab4-6f3d-44f4-952b-0a2aa7915679
• NDC: 65084-453
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocodone Bitatrate and Acetaminophen
• Generic Name: Hydrocodone Bitatrate And Acetaminophen
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-03-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040148
• Labeler Name: Mckesson Rxpak Inc
• Substance Name: HYDROCODONE BITARTRATE; ACETAMINOPHEN
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 65084-453-10

100 TABLET in 1 BOTTLE, PLASTIC (65084-453-10)

• Marketing Start Date: 2013-03-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65084-453-10 [65084045310]

Hydrocodone Bitatrate and Acetaminophen TABLET

• Marketing Category: ANDA
• Application Number: ANDA040148
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-03-12
• Marketing End Date: 2018-01-01

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE BITARTRATE	10 mg/1

OpenFDA Data

• SPL SET ID: d08cc0ab-4cb5-4290-8d46-5d8b66e8472e
• Manufacturer:
  • Mckesson Rxpak Inc
• UNII:
  • 362O9ITL9D
  • NO70W886KK
• RxNorm Concept Unique ID - RxCUI:
  • 856999

Pharmacological Class

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

NDC Crossover Matching brand name "Hydrocodone Bitatrate and Acetaminophen" or generic name "Hydrocodone Bitatrate And Acetaminophen"

NDC	Brand Name	Generic Name
55700-216	Hydrocodone Bitatrate and Acetaminophen	Hydrocodone Bitatrate and Acetaminophen
65084-453	Hydrocodone Bitatrate and Acetaminophen	Hydrocodone Bitatrate and Acetaminophen
52544-071	Norco	Hydrocodone Bitatrate and Acetaminophen
52544-161	Norco	Hydrocodone Bitatrate and Acetaminophen
52544-162	Norco	Hydrocodone Bitatrate and Acetaminophen
65084-288	Norco	Hydrocodone Bitatrate and Acetaminophen