71335-1216 : Oxycodone and Acetaminophen Oral Tablet

NDC:	71335-1216
Labeler:	Bryant Ranch Prepack
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA207419
Rev. Date:	Apr 11, 2017
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:	T192
Shapes:	Round
Colors:	Blue
Size (mm):	12
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:

71335-1216-0: 25 TABLET IN 1 BOTTLE (71335‑1216‑0)
71335-1216-1: 10 TABLET IN 1 BOTTLE (71335‑1216‑1)
71335-1216-2: 120 TABLET IN 1 BOTTLE (71335‑1216‑2)
71335-1216-3: 28 TABLET IN 1 BOTTLE (71335‑1216‑3)
71335-1216-4: 12 TABLET IN 1 BOTTLE (71335‑1216‑4)
71335-1216-5: 40 TABLET IN 1 BOTTLE (71335‑1216‑5)
71335-1216-6: 30 TABLET IN 1 BOTTLE (71335‑1216‑6)
71335-1216-7: 90 TABLET IN 1 BOTTLE (71335‑1216‑7)
71335-1216-8: 60 TABLET IN 1 BOTTLE (71335‑1216‑8)
71335-1216-9: 84 TABLET IN 1 BOTTLE (71335‑1216‑9)

Active Ingredients:

Oxycodone Hydrochloride
Acetaminophen

Dosage Strength:

5 mg
325 mg

Inactive Ingredients:

Silicon Dioxide
Crospovidone, Unspecified
Microcrystalline Cellulose
Croscarmellose Sodium
Povidone, Unspecified
Starch, Corn
Stearic Acid
Fd&c Blue No. 1 /

Pharmaceutical Classes:

Full Opioid Agonists [MoA]
Opioid Agonist [EPC]

NDC QR Code

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NDC 71335-1216 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.