67544-023 : Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet


NDC: 67544-023
Labeler: Aphena Pharma Solutions - Tennessee, 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: (67544-023) Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, 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:

  • 67544-023-10: 10 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑10)
  • 67544-023-15: 15 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑15)
  • 67544-023-20: 20 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑20)
  • 67544-023-25: 25 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑25)
  • 67544-023-28: 28 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑28)
  • 67544-023-30: 30 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑30)
  • 67544-023-40: 40 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑40)
  • 67544-023-45: 45 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑45)
  • 67544-023-46: 56 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑46)
  • 67544-023-50: 50 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑50)
  • 67544-023-53: 60 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑53)
  • 67544-023-54: 84 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑54)
  • 67544-023-55: 75 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑55)
  • 67544-023-57: 80 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑57)
  • 67544-023-60: 90 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑60)
  • 67544-023-61: 70 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑61)
  • 67544-023-63: 160 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑63)
  • 67544-023-67: 168 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑67)
  • 67544-023-70: 120 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑70)
  • 67544-023-72: 112 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑72)
  • 67544-023-75: 150 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑75)
  • 67544-023-77: 140 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑77)
  • 67544-023-80: 180 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑80)
  • 67544-023-90: 240 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑90)
  • 67544-023-94: 360 TABLET IN 1 BOTTLE, PLASTIC (67544‑023‑94)

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.
  • 67544-024 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 67544-025 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 67544-026 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 67544-269 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 67544-397 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 67544-670 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 67544-750 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-017 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-159 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-187 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-324 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-422 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-503 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-721 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-734 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, 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.
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NDC QR Code

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NDC 67544-023 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.