0406-0123 : Hydrocodone Bitartrate and Acetaminophen Oral Tablet

NDC:	0406-0123
Labeler:	Mallinckrodt, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040409
Rev. Date:	Sep 1, 2014
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:	M365
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.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 0406-0123-01: 100 TABLET IN 1 BOTTLE (0406‑0123‑01)
• 0406-0123-05: 500 TABLET IN 1 BOTTLE (0406‑0123‑05)
• 0406-0123-10: 1000 TABLET IN 1 BOTTLE (0406‑0123‑10)
• 0406-0123-12: 120 TABLET IN 1 BOTTLE (0406‑0123‑12)
• 0406-0123-20: 20 TABLET IN 1 BOTTLE (0406‑0123‑20)
• 0406-0123-23: 1 TABLET IN 1 BLISTER PACK (0406‑0123‑23)
• 0406-0123-30: 30 TABLET IN 1 BOTTLE (0406‑0123‑30)
• 0406-0123-60: 60 TABLET IN 1 BOTTLE (0406‑0123‑60)
• 0406-0123-62: 100 TABLET IN 1 BLISTER PACK (0406‑0123‑62)
• 0406-0123-90: 90 TABLET IN 1 BOTTLE (0406‑0123‑90)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0406-0124 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0125 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0357 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0358 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0359 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0360 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0361 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0362 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0363 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0364 Apap 750 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0365 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0366 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0367 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0376 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0377 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-0378 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
• 0406-4357 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Capsule by Mallinckrodt Inc.
• 0121-0655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-0772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-1544 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
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