10544-315 : Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet

NDC:	10544-315
Labeler:	Blenheim Pharmacal, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040729
Rev. Date:	Jan 16, 2008
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:	IP;111
Shapes:	Capsule
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.

NDC Package Codes:

• 10544-315-02: 112 TABLET IN 1 BOTTLE (10544‑315‑02)
• 10544-315-04: 140 TABLET IN 1 BOTTLE (10544‑315‑04)
• 10544-315-28: 28 TABLET IN 1 BOTTLE (10544‑315‑28)
• 10544-315-30: 30 TABLET IN 1 BOTTLE (10544‑315‑30)
• 10544-315-60: 60 TABLET IN 1 BOTTLE (10544‑315‑60)
• 10544-315-84: 84 TABLET IN 1 BOTTLE (10544‑315‑84)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 10544-008 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, Inc.
• 10544-202 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, Inc.
• 10544-203 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, Inc.
• 10544-206 Hydrocodone Bitartrate and Acetaminophen (Hydrocodone Bitartrate 750 mg / Acetaminophen 750 mg) by Blenheim Pharmacal, Inc.
• 10544-574 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Blenheim Pharmacal, Inc.
• 10544-611 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, Inc.
• 10544-612 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, 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.
• 0121-4772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0179-0112 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-0113 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-0116 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-1026 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-1957 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Kaiser Foundation Hospitals
• 0245-0410 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Upsher-smith Laboratories, Inc.
• More related products ...

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