NDC 0904-6419

Hydrocodone Bitartate and Acetaminophen

Hydrocodone Bitartate And Acetaminophen

Hydrocodone Bitartate and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Hydrocodone Bitartrate; Acetaminophen.

• Product ID: 0904-6419_0720c952-aba8-4c71-90ee-d0081cabeae6
• NDC: 0904-6419
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocodone Bitartate and Acetaminophen
• Generic Name: Hydrocodone Bitartate And Acetaminophen
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-02-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040099
• Labeler Name: Major Pharmaceuticals
• Substance Name: HYDROCODONE BITARTRATE; ACETAMINOPHEN
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
• DEA Schedule: CII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0904-6419-61

100 TABLET in 1 BOX, UNIT-DOSE (0904-6419-61)

• Marketing Start Date: 2015-02-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-6419-61 [00904641961]

Hydrocodone Bitartate and Acetaminophen TABLET

• Marketing Category: ANDA
• Application Number: ANDA040099
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-05
• Marketing End Date: 2019-01-31

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE BITARTRATE	5 mg/1

OpenFDA Data

• SPL SET ID: 00fda976-83fd-4b58-8ef7-1bf04e9c5a00
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 362O9ITL9D
  • NO70W886KK
• RxNorm Concept Unique ID - RxCUI:
  • 857002

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0904-6419	Hydrocodone Bitartate and Acetaminophen	Hydrocodone Bitartate and Acetaminophen
33261-881	Hydrocodone Bitartate and Acetaminophen	HYDROCODONE BITARTRATE, ACETAMINOPHEN
42254-300	Hydrocodone Bitartate and Acetaminophen	HYDROCODONE BITARTRATE, ACETAMINOPHEN
51655-900	HYDROCODONE BITARTATE AND ACETAMINOPHEN	HYDROCODONE BITARTATE AND ACETAMINOPHEN
63629-5428	Hydrocodone Bitartate and Acetaminophen	HYDROCODONE BITARTRATE, ACETAMINOPHEN
76519-1011	Hydrocodone Bitartate and Acetaminophen	HYDROCODONE BITARTRATE, ACETAMINOPHEN