42254-300 : Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet

NDC:	42254-300
Labeler:	Rebel Distributors Corp
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040846
Rev. Date:	May 17, 2012
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:	2;5;325;KLE
Shapes:	Capsule
Colors:	White
Size (mm):	22
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 42254-300-30: 30 TABLET IN 1 BOTTLE, PLASTIC (42254‑300‑30)
• 42254-300-60: 60 TABLET IN 1 BOTTLE, PLASTIC (42254‑300‑60)
• 42254-300-90: 90 TABLET IN 1 BOTTLE, PLASTIC (42254‑300‑90)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Silicon Dioxide
• Crospovidone
• Magnesium Stearate
• Cellulose, Microcrystalline
• Povidone
• Starch, Corn
• Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0591-3202 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Watson Laboratories, Inc.
• 0904-6419 Hydrocodone Bitartate and Acetaminophen Oral Tablet by Major Pharmaceuticals
• 33261-881 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Aidarex Pharmaceuticals LLC
• 35356-766 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
• 50436-3912 Hydrocodone Bitartate and Acetaminophen Oral Tablet by Unit Dose Services
• 51655-900 Hydrocodone Bitartate and Acetaminophen Oral Tablet by Northwind Pharmaceuticals
• 54569-6362 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by A-s Medication Solutions LLC
• 63629-4731 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Bryant Ranch Prepack
• 63629-5428 Hydrocodone Bitartate and Acetaminophen Oral Tablet by Bryant Ranch Prepack
• 68788-9754 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Preferred Pharmaceuticals, Inc.
• 76218-1828 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Kle 2, Inc.
• 76519-1011 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by H.j. Harkins Company, Inc.

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