0406-0357 : Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet

NDC:	0406-0357
Labeler:	Mallinckrodt, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA089160
Rev. Date:	Apr 22, 2010
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:	M357
Shapes:	Oval
Colors:	White
Size (mm):	17
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.

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:

• 0406-0357-01: 100 TABLET IN 1 BOTTLE (0406‑0357‑01)
• 0406-0357-05: 500 TABLET IN 1 BOTTLE (0406‑0357‑05)
• 0406-0357-09: 90 TABLET IN 1 BOTTLE (0406‑0357‑09)
• 0406-0357-23: 1 TABLET IN 1 BLISTER PACK (0406‑0357‑23)
• 0406-0357-62: 100 TABLET IN 1 BLISTER PACK (0406‑0357‑62)
• 0406-0357-92: 1000 TABLET IN 1 BOTTLE (0406‑0357‑92)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0406-0123 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0124 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0125 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0358 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0359 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0360 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0361 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0362 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0363 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0364 Apap 750 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0365 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0366 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0367 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0376 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0377 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0378 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-4357 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Capsule by Mallinckrodt Inc.
• 0121-0655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
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