10544-612 : Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet


NDC10544-612
Labeler: Blenheim Pharmacal, 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 Blenheim Pharmacal, 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:

  • 10544-612-10: 10 TABLET IN 1 BOTTLE (10544‑612‑10)
  • 10544-612-12: 12 TABLET IN 1 BOTTLE (10544‑612‑12)
  • 10544-612-15: 15 TABLET IN 1 BOTTLE (10544‑612‑15)
  • 10544-612-20: 20 TABLET IN 1 BOTTLE (10544‑612‑20)
  • 10544-612-30: 30 TABLET IN 1 BOTTLE (10544‑612‑30)

Active Ingredients:

  • Acetaminophen
  • Hydrocodone Bitartrate

Dosage Strength:

  • 500 mg
  • 5 mg

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 10544-008 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-202 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-203 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-206 Hydrocodone Bitartrate and Acetaminophen (Hydrocodone Bitartrate 750 mg / Acetaminophen 750 mg) by Blenheim Pharmacal, Inc.
  • 10544-315 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-574 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-611 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Blenheim Pharmacal, 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.
  • 0121-2316 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-4655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-4771 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-4772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0179-0112 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-0113 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-0116 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-1026 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-1957 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0245-0410 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Upsher-smith Laboratories, Inc.
  • More related products ...

NDC QR Code

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NDC 10544-612 QR Code

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