0406-0357 : Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet


NDC0406-0357
Labeler: Mallinckrodt, Inc.
Product Type: Human Prescription Drug
Drug Name:  Hydrocodone Bitartrate and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA089160
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: M357
Shapes:  Oval
Colors:  White
Size (mm): 17
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.

M357: (0406-0357) Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Mallinckrodt, Inc.
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:

  • 0406-0357-01: 100 TABLET IN 1 BOTTLE (0406‑0357‑01)
  • 0406-0357-05: 500 TABLET IN 1 BOTTLE (0406‑0357‑05)
  • 0406-0357-09: 90 TABLET IN 1 BOTTLE (0406‑0357‑09)
  • 0406-0357-23: 1 TABLET IN 1 BLISTER PACK (0406‑0357‑23)
  • 0406-0357-62: 100 TABLET IN 1 BLISTER PACK (0406‑0357‑62)
  • 0406-0357-92: 1000 TABLET IN 1 BOTTLE (0406‑0357‑92)

Active Ingredients:

  • Acetaminophen
  • Hydrocodone Bitartrate

Dosage Strength:

  • 500 mg
  • 5 mg

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.
  • 0406-0123 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
  • 0406-0124 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mallinckrodt, Inc.
  • 0406-0125 Hydrocodone Bitartrate and Acetaminophen 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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NDC QR Code

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NDC 0406-0357 QR Code

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