46672-192 : Apap 300 mg / Hydrocodone Bitartrate 10 mg Oral Tablet


NDC46672-192
Labeler: Mikart, Inc.
Product Type: Human Prescription Drug
Drug Name: Hydrocodone Bitartrate and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA040556
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 10;300;TP
Shapes:  Oval
Colors:  White
Size (mm): 14
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:

  • 46672-192-10: 100 TABLET IN 1 BOTTLE, PLASTIC (46672‑192‑10)
  • 46672-192-50: 500 TABLET IN 1 BOTTLE, PLASTIC (46672‑192‑50)

Active Ingredients:

  • Hydrocodone Bitartrate
  • Acetaminophen

Dosage Strength:

  • 10 mg
  • 300 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Crospovidone
  • Magnesium Stearate
  • Povidones
  • Silicon Dioxide
  • Starch, Corn
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 46672-036 Apap 300 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Mikart, Inc.
  • 46672-092 Apap 325 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Mikart, Inc.
  • 46672-147 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Mikart, Inc.
  • 46672-166 Apap 300 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mikart, Inc.
  • 46672-200 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Capsule by Mikart, Inc.
  • 46672-642 Hydrocodone Bitartrate and Acetaminophen Oral Syrup by Mikart, Inc.
  • 46672-645 Hydrocodone Bitartrate and Acetaminophen Oral Syrup by Mikart, Inc.
  • 46672-052 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Mikart Inc.
  • 0258-3622 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mikart, Inc.
  • 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.
  • 0121-4655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-4771 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-4772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0179-0112 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-0113 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-0116 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-1026 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
  • More related products ...

NDC QR Code

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NDC 46672-192 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.