54868-4974 : Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet

NDC:	54868-4974
Labeler:	Physicians Total Care, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040400
Rev. Date:	Jan 13, 2004
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:	M367
Shapes:	Oval
Colors:	White
Size (mm):	15
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:

• 54868-4974-0: 60 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑0)
• 54868-4974-1: 30 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑1)
• 54868-4974-3: 90 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑3)
• 54868-4974-4: 40 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑4)
• 54868-4974-5: 20 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑5)
• 54868-4974-6: 100 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑6)
• 54868-4974-7: 120 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑7)
• 54868-4974-8: 150 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑8)
• 54868-4974-9: 180 TABLET IN 1 BOTTLE, PLASTIC (54868‑4974‑9)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 54868-0071 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-2281 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-3038 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-3585 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-3729 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-4237 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-4747 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Physicians Total Care, Inc.
• 54868-5059 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-5146 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-5167 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Physicians Total Care, Inc.
• 54868-6407 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Physicians Total Care, Inc.
• 54868-6437 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Physicians Total Care, Inc.
• 0121-0655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-0772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-1544 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-2316 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4771 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
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• 0179-0112 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
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