63187-933 : Butalbital, Acetaminophen, and Caffeine Oral Tablet


NDC63187-933
Labeler: Proficient Rx Lp
Product Type: Human Prescription Drug
Drug Name:  Butalbital, Acetaminophen, and Caffeine
Dosage Form: Oral Tablet
Application #: ANDA200243
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: LCI;1695
Shapes:  Round
Colors:  Blue
Size (mm): 11
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.

LCI 1695: (0527-1695) Butalbital, Acetaminophen, and Caffeine Oral Tablet by Proficient Rx Lp
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:

  • 63187-933-14: 14 TABLET IN 1 BOTTLE, PLASTIC (63187‑933‑14)
  • 63187-933-30: 30 TABLET IN 1 BOTTLE, PLASTIC (63187‑933‑30)
  • 63187-933-60: 60 TABLET IN 1 BOTTLE, PLASTIC (63187‑933‑60)
  • 63187-933-90: 90 TABLET IN 1 BOTTLE, PLASTIC (63187‑933‑90)

Active Ingredients:

  • Acetaminophen
  • Butalbital
  • Caffeine

Dosage Strength:

  • 325 mg
  • 50 mg
  • 40 mg

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Crospovidone, Unspecified
  • Croscarmellose Sodium
  • Starch, Corn
  • Stearic Acid
  • Silicon Dioxide
  • Magnesium Stearate
  • Fd&c Blue No. 1

Pharmaceutical Classes:

  • Barbiturate [EPC]
  • Barbiturates [CS]
  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]
  • Methylxanthine [EPC]
  • Xanthines [CS]

Related Products:

Based on records with the same trade name.
  • 63187-520 Butalbital, Acetaminophen and Caffeine Oral Tablet by Proficient Rx Lp
  • 71205-962 Butalbital, Acetaminophen and Caffeine Oral Capsule by Proficient Rx Lp
  • 0143-0170 Butalbital, Acetaminophen, and Caffeine Oral Capsule by West-ward Pharmaceutical Corp
  • 0143-1115 Apap 500 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by West-ward Pharmaceutical Corp
  • 0143-1787 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by West-ward Pharmaceutical Corp
  • 0179-0137 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0527-1695 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by Lannett Company, Inc.
  • 0527-4094 Butalbital, Acetaminophen and Caffeine Oral Capsule by Lannett Company, Inc.
  • 0527-4095 Butalbital, Acetaminophen, and Caffeine Oral Capsule by Lannett Company, Inc.
  • 0591-2640 Apap 300 mg / Butalbital 50 mg / Caffeine 40 mg Oral Capsule by Watson Pharma, Inc.
  • 0591-3369 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by Watson Laboratories, Inc.
  • 0603-2544 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-2545 Apap 500 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0722-7029 Apap 300 mg / Butalbital 50 mg / Caffeine 40 mg Oral Capsule by Nexgen Pharma, Inc.
  • 0722-7320 Butalbital, Acetaminophen, and Caffeine Oral Tablet by Nexgen Pharma, Inc.
  • 0904-6538 Butalbital, Acetaminophen and Caffeine Oral Tablet by Major Pharmaceuticals
  • 0904-6938 Butalbital, Acetaminophen, and Caffeine Oral Tablet by Major Pharmaceuticals
  • 10135-628 Butalbital, Acetaminophen and Caffeine Oral Capsule by Marlex Pharmaceuticals Inc
  • 10702-253 Butalbital, Acetaminophen and Caffeine Oral Tablet by Kvk-tech, Inc.
  • 11534-187 Butalbital, Acetaminophen and Caffeine Oral Capsule by Sunrise Pharmaceutical, Inc
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NDC 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.