76519-1011 : Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet

NDC:	76519-1011
Labeler:	H.j. Harkins Company, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040846
Rev. Date:	May 17, 2012
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:	2;5;325;KLE
Shapes:	Capsule
Colors:	White
Size (mm):	22
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 76519-1011-0: 100 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑0)
• 76519-1011-1: 12 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑1)
• 76519-1011-2: 20 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑2)
• 76519-1011-3: 30 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑3)
• 76519-1011-4: 40 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑4)
• 76519-1011-5: 15 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑5)
• 76519-1011-6: 60 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑6)
• 76519-1011-7: 75 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑7)
• 76519-1011-8: 120 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑8)
• 76519-1011-9: 90 TABLET IN 1 BOTTLE, PLASTIC (76519‑1011‑9)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0591-3202 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Watson Laboratories, Inc.
• 0904-6419 Hydrocodone Bitartate and Acetaminophen Oral Tablet by Major Pharmaceuticals
• 33261-881 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Aidarex Pharmaceuticals LLC
• 35356-766 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
• 42254-300 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Rebel Distributors Corp
• 50436-3912 Hydrocodone Bitartate and Acetaminophen Oral Tablet by Unit Dose Services
• 51655-900 Hydrocodone Bitartate and Acetaminophen Oral Tablet by Northwind Pharmaceuticals
• 54569-6362 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by A-s Medication Solutions LLC
• 63629-4731 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Bryant Ranch Prepack
• 63629-5428 Hydrocodone Bitartate and Acetaminophen Oral Tablet by Bryant Ranch Prepack
• 68788-9754 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Preferred Pharmaceuticals, Inc.
• 76218-1828 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Kle 2, Inc.

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