55289-268 : Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet

NDC:	55289-268
Labeler:	Pd-rx Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040748
Rev. Date:	Feb 18, 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:	IP;112
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:

• 55289-268-10: 10 TABLET IN 1 BOTTLE, PLASTIC (55289‑268‑10)
• 55289-268-20: 20 TABLET IN 1 BOTTLE, PLASTIC (55289‑268‑20)
• 55289-268-30: 30 TABLET IN 1 BOTTLE, PLASTIC (55289‑268‑30)
• 55289-268-45: 45 TABLET IN 1 BOTTLE, PLASTIC (55289‑268‑45)
• 55289-268-60: 60 TABLET IN 1 BOTTLE, PLASTIC (55289‑268‑60)
• 55289-268-90: 90 TABLET IN 1 BOTTLE, PLASTIC (55289‑268‑90)
• 55289-268-98: 120 TABLET IN 1 BOTTLE, PLASTIC (55289‑268‑98)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 55289-137 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 55289-311 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 55289-360 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 55289-534 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 55289-737 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 55289-802 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 55289-965 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 55289-997 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-004 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-091 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-265 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-327 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-338 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-339 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-355 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-356 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-357 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-359 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-360 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-361 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• More related products ...

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