42254-340 : Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet

NDC:	42254-340
Labeler:	Rebel Distributors Corp
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA090118
Rev. Date:	Mar 30, 2009
CSA Schedule:	CIII (US) [1]

^[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	126
Shapes:	Capsule
Colors:	White
Size (mm):	14
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 42254-340-12: 12 TABLET IN 1 BOTTLE (42254‑340‑12)
• 42254-340-30: 30 TABLET IN 1 BOTTLE (42254‑340‑30)
• 42254-340-60: 60 TABLET IN 1 BOTTLE (42254‑340‑60)
• 42254-340-90: 90 TABLET IN 1 BOTTLE (42254‑340‑90)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Croscarmellose Sodium
• Crospovidone
• Magnesium Stearate
• Cellulose, Microcrystalline
• Povidones
• Starch, Corn
• Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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