71335-1417 : Hydrocodone Bitartrate and Acetaminophen Oral Tablet

NDC:	71335-1417
Labeler:	Bryant Ranch Prepack
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA202991
Rev. Date:	Apr 12, 2016
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:	R;P;H5;325
Shapes:	Oval
Colors:	White
Size (mm):	15
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:

71335-1417-0: 10 TABLET IN 1 BOTTLE (71335‑1417‑0)
71335-1417-1: 30 TABLET IN 1 BOTTLE (71335‑1417‑1)
71335-1417-2: 120 TABLET IN 1 BOTTLE (71335‑1417‑2)
71335-1417-3: 20 TABLET IN 1 BOTTLE (71335‑1417‑3)
71335-1417-4: 60 TABLET IN 1 BOTTLE (71335‑1417‑4)
71335-1417-5: 90 TABLET IN 1 BOTTLE (71335‑1417‑5)
71335-1417-6: 8 TABLET IN 1 BOTTLE (71335‑1417‑6)
71335-1417-7: 40 TABLET IN 1 BOTTLE (71335‑1417‑7)
71335-1417-8: 15 TABLET IN 1 BOTTLE (71335‑1417‑8)
71335-1417-9: 84 TABLET IN 1 BOTTLE (71335‑1417‑9)

Active Ingredients:

Hydrocodone Bitartrate
Acetaminophen

Dosage Strength:

5 mg
325 mg

Inactive Ingredients:

Silicon Dioxide
Magnesium Stearate
Crospovidone, Unspecified
Povidone K30
Starch, Corn
Stearic Acid /

Pharmaceutical Classes:

Opioid Agonist [EPC]
Opioid Agonists [MoA]

NDC QR Code

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NDC 71335-1417 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.