0406-0484 : Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet

NDC:	0406-0484
Labeler:	Mallinckrodt, 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:

• 0406-0484-01: 100 TABLET IN 1 BOTTLE (0406‑0484‑01)
• 0406-0484-03: 30 TABLET IN 1 BOTTLE (0406‑0484‑03)
• 0406-0484-10: 1000 TABLET IN 1 BOTTLE (0406‑0484‑10)
• 0406-0484-20: 20 TABLET IN 1 BOTTLE (0406‑0484‑20)
• 0406-0484-23: 1 TABLET IN 1 BLISTER PACK (0406‑0484‑23)
• 0406-0484-50: 50 TABLET IN 1 BOTTLE (0406‑0484‑50)
• 0406-0484-62: 100 TABLET IN 1 BLISTER PACK (0406‑0484‑62)

Active Ingredients:

• Acetaminophen
• Codeine Phosphate

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0406-0483 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0485 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Mallinckrodt, 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.
• 0603-1020 Acetaminophen and Codeine Phosphate Oral Solution by Qualitest Pharmaceuticals
• 0615-7792 Acetaminophen and Codeine Phosphate Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
• 0615-8102 Acetaminophen and Codeine Phosphate Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
• 0785-6270 Apap 650 mg / Codeine Phosphate 60 mg Oral Tablet by Uad Laboratories
• 10544-032 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Blenheim Pharmacal, Inc.
• 12634-266 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Apotheca, Inc.
• 12634-267 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Apotheca, Inc.
• 12634-526 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Apotheca, Inc.
• 12634-975 Acetaminophen and Codeine Phosphate Oral Solution by Apotheca, Inc.
• 13107-058 Apap 300 mg / Codeine Phosphate 15 mg Oral Tablet by Aurolife Pharma, LLC
• 13107-059 Apap 300 mg / Codeine Phosphate 30 mg Oral Tablet by Aurolife Pharma, LLC
• 13107-060 Apap 300 mg / Codeine Phosphate 60 mg Oral Tablet by Aurolife Pharma, LLC
• 16590-361 Acetaminophen and Codeine Phosphate Oral Solution by Stat Rx USA LLC
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