42254-214 : Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet


NDC42254-214
Labeler: Rebel Distributors Corp
Product Type: Human Prescription Drug
Drug Name: Hydrocodone Bitartrate and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA090118
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: 176
Shapes:  Oval
Colors:  White
Size (mm): 13
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:

  • 42254-214-00: 100 TABLET IN 1 BOTTLE (42254‑214‑00)
  • 42254-214-20: 20 TABLET IN 1 BOTTLE (42254‑214‑20)
  • 42254-214-30: 30 TABLET IN 1 BOTTLE (42254‑214‑30)
  • 42254-214-60: 60 TABLET IN 1 BOTTLE (42254‑214‑60)
  • 42254-214-90: 90 TABLET IN 1 BOTTLE (42254‑214‑90)

Active Ingredients:

  • Acetaminophen
  • Hydrocodone Bitartrate

Dosage Strength:

  • 325 mg
  • 10 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone
  • Starch, Corn
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 42254-079 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
  • 42254-100 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Rebel Distributors Corp
  • 42254-223 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp
  • 42254-228 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp
  • 42254-244 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
  • 42254-340 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Rebel Distributors Corp
  • 42254-346 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
  • 21695-268 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Rebel Distributors Corp
  • 21695-273 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
  • 21695-274 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
  • 21695-386 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp
  • 21695-436 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Rebel Distributors Corp
  • 21695-508 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
  • 21695-579 Apap 500 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Rebel Distributors Corp
  • 21695-816 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Rebel Distributors Corp
  • 21695-987 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Rebel Distributors Corp
  • 0121-0655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-0772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-1544 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-2316 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • More related products ...

NDC QR Code

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NDC 42254-214 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.