0603-3887 : Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet

NDC:	0603-3887
Labeler:	Qualitest Pharmaceuticals
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040355
Rev. Date:	May 31, 2000
CSA Schedule:	CII (US) [1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	3601;V
Shapes:	Oval
Colors:	Yellow
Size (mm):	14
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:

• 0603-3887-02: 90 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑02)
• 0603-3887-04: 180 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑04)
• 0603-3887-12: 240 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑12)
• 0603-3887-20: 60 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑20)
• 0603-3887-21: 100 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑21)
• 0603-3887-22: 120 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑22)
• 0603-3887-26: 150 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑26)
• 0603-3887-28: 500 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑28)
• 0603-3887-32: 1000 TABLET IN 1 BOTTLE, PLASTIC (0603‑3887‑32)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• D&c Yellow No. 10
• Magnesium Stearate
• Cellulose, Microcrystalline
• Povidones
• Starch, Corn
• Stearic Acid
• Crospovidone

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0603-3609 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Qualitest Pharmaceuticals
• 0603-3880 Apap 500 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3881 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3882 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3883 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3884 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3885 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3886 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3888 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3890 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-3891 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Qualitest Pharmaceuticals
• 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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