0143-3000 : Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule


NDC0143-3000
Labeler: West-ward Pharmaceutical Corp
Product Type: Human Prescription Drug
Drug Name:  Butalbital, Acetaminophen and Caffeine With Codeine Phosphate
Dosage Form: Oral Capsule
Application #: ANDA075618
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:


Shapes:  Capsule
Colors:  Blue / Gray
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:

  • 0143-3000-01: 100 CAPSULE IN 1 BOTTLE, PLASTIC (0143‑3000‑01)
  • 0143-3000-05: 500 CAPSULE IN 1 BOTTLE, PLASTIC (0143‑3000‑05)
  • 0143-3000-30: 30 CAPSULE IN 1 BOTTLE, PLASTIC (0143‑3000‑30)

Active Ingredients:

  • Acetaminophen
  • Butalbital
  • Caffeine
  • Codeine Phosphate

Dosage Strength:

  • 325 mg
  • 50 mg
  • 40 mg
  • 30 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Fd&c Blue No. 2
  • Gelatin
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Ferric Oxide Red
  • Sodium Lauryl Sulfate
  • Sodium Starch Glycolate Type a Potato
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • Fd&c Red No. 3

Pharmaceutical Classes:

  • Barbiturate [EPC]
  • Barbiturates [Chemical/Ingredient]
  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]
  • Methylxanthine [EPC]
  • Xanthines [Chemical/Ingredient]
  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

NDC QR Code

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NDC 0143-3000 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.