68071-4533 : Acetaminophen and Codeine Phosphate Oral Tablet

NDC:	68071-4533
Labeler:	Nucare Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Acetaminophen and Codeine Phosphate
Dosage Form:	Oral Tablet
Application #:	ANDA040419
Rev. Date:	Jul 6, 2011
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:	3;M
Shapes:	Round
Colors:	White
Size (mm):	11
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.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 68071-4533-2: 20 TABLET IN 1 BOTTLE (68071‑4533‑2)
• 68071-4533-3: 30 TABLET IN 1 BOTTLE (68071‑4533‑3)
• 68071-4533-4: 24 TABLET IN 1 BOTTLE (68071‑4533‑4)
• 68071-4533-5: 15 TABLET IN 1 BOTTLE (68071‑4533‑5)
• 68071-4533-6: 60 TABLET IN 1 BOTTLE (68071‑4533‑6)
• 68071-4533-8: 84 TABLET IN 1 BOTTLE (68071‑4533‑8)

Active Ingredients:

• Acetaminophen
• Codeine Phosphate

Inactive Ingredients:

• Crospovidone (15 Mpa.s At 5%)
• Magnesium Stearate
• Microcrystalline Cellulose
• Povidone, Unspecified
• Starch, Corn
• Stearic Acid /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 68071-2681 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-2800 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-3061 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-3100 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-3272 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-4430 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-4475 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-4668 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-4673 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-4749 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-5010 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 68071-5025 Acetaminophen and Codeine Phosphate Oral Tablet by Nucare Pharmaceuticals, Inc.
• 66267-997 Acetaminophen and Codeine Phosphate Oral Solution by Nucare Pharmaceuticals, Inc.
• 0093-0050 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Teva Pharmaceuticals USA Inc
• 0093-0150 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Teva Pharmaceuticals USA Inc
• 0093-0350 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Teva Pharmaceuticals USA Inc
• 0121-0504 Acetaminophen and Codeine Phosphate Oral Solution by Pharmaceutical Associates, Inc.
• 0121-1008 Acetaminophen and Codeine Phosphate Oral Solution by Pharmaceutical Associates, Inc.
• 0406-0483 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0484 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Mallinckrodt, Inc.
• More related products ...

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