51862-544 : Butalbital and Acetaminophen Oral Capsule


NDC51862-544
Labeler: Mayne Pharma
Product Type: Human Prescription Drug
Drug Name:  Butalbital and Acetaminophen
Dosage Form: Oral Capsule
Application #: ANDA207313
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: mayne;544
Shapes:  Capsule
Colors:  Purple
Size (mm): 22
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 51862-544-01: 100 CAPSULE IN 1 BOTTLE (51862‑544‑01)
  • 51862-544-05: 500 CAPSULE IN 1 BOTTLE (51862‑544‑05)

Active Ingredients:

  • Butalbital
  • Acetaminophen

Dosage Strength:

  • 50 mg
  • 300 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Crospovidone
  • Cellulose, Microcrystalline
  • Silicon Dioxide
  • Stearic Acid
  • Povidone, Unspecified
  • Starch, Corn
  • Gelatin
  • Titanium Dioxide
  • Fd&c Blue No. 1
  • Fd&c Red No. 3 /

Pharmaceutical Classes:

  • Barbiturates [CS]
  • Barbiturate [EPC]

Related Products:

Based on records with the same trade name.
  • 51862-538 Butalbital and Acetaminophen Oral Tablet by Mayne Pharma
  • 0603-2540 Apap 325 mg / Butalbital 50 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0722-7075 Apap 300 mg / Butalbital 50 mg Oral Tablet by Nexgen Pharma, Inc.
  • 13517-109 Butalbital and Acetaminophen Oral Tablet by E5 Pharma, LLC
  • 35573-455 Butalbital and Acetaminophen Oral Tablet by Burel Pharmaceuticals, LLC
  • 35573-456 Butalbital and Acetaminophen Oral Tablet by Burel Pharmaceuticals, LLC
  • 42549-495 Apap 650 mg / Butalbital 50 mg Oral Tablet by Stat Rx USA LLC
  • 43199-053 Butalbital and Acetaminophen Oral Tablet by County Line Pharmaceuticals, LLC
  • 46672-098 Apap 650 mg / Butalbital 50 mg Oral Tablet by Mikart, Inc.
  • 46672-286 Butalbital and Acetaminophen Oral Capsule by Mikart, Inc.
  • 46672-856 Butalbital and Acetaminophen Oral Tablet by Mikart, Inc.
  • 47781-534 Butalbital and Acetaminophen Oral Tablet by Alvogen Inc.
  • 47781-535 Butalbital and Acetaminophen Oral Tablet by Alvogen, Inc.
  • 47781-628 Butalbital and Acetaminophen Oral Tablet by Alvogen, Inc.
  • 47781-644 Butalbital and Acetaminophen Oral Tablet by Alvogen Inc.
  • 54879-026 Butalbital and Acetaminophen Oral Tablet by Sti Pharma LLC
  • 68047-721 Butalbital and Acetaminophen Oral Tablet by Larken Laboratories, Inc.
  • 68047-753 Butalbital and Acetaminophen Oral Tablet by Larken Laboratories, Inc.
  • 68682-306 Butalbital and Acetaminophen Oral Tablet by Oceanside Pharmaceuticals
  • 69499-342 Butalbital and Acetaminophen Oral Capsule by Solubiomix
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NDC QR Code

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NDC 51862-544 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.