52544-634 : Maxidone 10/750 (Hydrocodone Bitartrate / Apap) Oral Tablet


NDC52544-634
Labeler: Watson Pharma, Inc.
Product Type: Human Prescription Drug
Drug Name:  Maxidone
Dosage Form: Oral Tablet
Application #: ANDA040094
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: Maxidone;634
Shapes:  Oval
Colors:  Yellow
Size (mm): 19
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:

  • 52544-634-01: 100 TABLET IN 1 BOTTLE (52544‑634‑01)
  • 52544-634-05: 500 TABLET IN 1 BOTTLE (52544‑634‑05)

Active Ingredients:

  • Acetaminophen
  • Hydrocodone Bitartrate

Dosage Strength:

  • 750 mg
  • 10 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • D&c Yellow No. 10
  • Aluminum Oxide
  • Stearic Acid
  • Povidones
  • Crospovidone
  • Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 52544-163 Maxidone 10/750 (Hydrocodone Bitartrate / Apap) Oral Tablet by Watson Pharma, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 52544-634 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.