21695-268 : Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet

NDC:	21695-268
Labeler:	Rebel Distributors Corp
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA076642
Rev. Date:	Sep 22, 2009
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:	IP;109
Shapes:	Round
Colors:	White
Size (mm):	10
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:

• 21695-268-15: 15 TABLET IN 1 BOTTLE (21695‑268‑15)
• 21695-268-28: 28 TABLET IN 1 BOTTLE (21695‑268‑28)
• 21695-268-30: 30 TABLET IN 1 BOTTLE (21695‑268‑30)
• 21695-268-60: 60 TABLET IN 1 BOTTLE (21695‑268‑60)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 21695-273 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
• 21695-274 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
• 21695-386 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp
• 21695-436 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp
• 21695-508 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
• 21695-579 Apap 500 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Rebel Distributors Corp
• 21695-816 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Rebel Distributors Corp
• 21695-987 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
• 21695-269 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Rebel Distributors Corp.
• 21695-270 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp.
• 21695-271 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp.
• 21695-272 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp.
• 42254-079 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
• 42254-100 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Rebel Distributors Corp
• 42254-214 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
• 42254-223 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp
• 42254-228 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp
• 42254-244 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
• 42254-340 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Rebel Distributors Corp
• 42254-346 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
• More related products ...

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