0603-2553 : Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule


NDC0603-2553
Labeler: Qualitest Pharmaceuticals
Product Type: Human Prescription Drug
Drug Name:  Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage Form: Oral Capsule
Application #: ANDA075929
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: V;3109
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.

V 3109: (0603-2553) Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Qualitest Pharmaceuticals
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:

  • 0603-2553-10: 10 CAPSULE IN 1 BOTTLE, PLASTIC (0603‑2553‑10)
  • 0603-2553-21: 100 CAPSULE IN 1 BOTTLE, PLASTIC (0603‑2553‑21)
  • 0603-2553-32: 1000 CAPSULE IN 1 BOTTLE, PLASTIC (0603‑2553‑32)

Active Ingredients:

  • Butalbital
  • Acetaminophen
  • Caffeine
  • Codeine Phosphate

Dosage Strength:

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

Inactive Ingredients:

  • Ferrosoferric Oxide
  • Silicon Dioxide
  • Fd&c Blue No. 1
  • Gelatin
  • Magnesium Stearate
  • Starch, Corn
  • Sodium Lauryl Sulfate
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0054-0650 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Oral Capsule by Hikma Pharmaceuticals USA Inc.
  • 0054-3000 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Oral Capsule by Hikma Pharmaceuticals USA Inc.
  • 0591-2641 Apap 300 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Watson Pharma, Inc.
  • 0591-3220 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Watson Laboratories, Inc.
  • 0722-6670 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Nexgen Pharma, Inc.
  • 0722-7028 Apap 300 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Nexgen Pharma, Inc.
  • 51991-073 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Breckenridge Pharmaceutical, Inc.
  • 54868-5162 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Physicians Total Care, Inc.
  • 63629-3152 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Bryant Ranch Prepack
  • 68258-2012 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Dispensing Solutions, Inc.
  • 71335-0194 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Oral Capsule by Bryant Ranch Prepack
  • 71335-0653 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Oral Capsule by Bryant Ranch Prepack
  • 72162-1591 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Oral Capsule by Bryant Ranch Prepack
  • 79739-6670 Acetaminophen 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Lgm Pharma Solutions LLC
  • 79739-7028 Acetaminophen 300 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Lgm Pharma Solutions, LLC

NDC QR Code

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NDC 0603-2553 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.