46672-645 : Hydrocodone Bitartrate and Acetaminophen Oral Syrup


NDC46672-645
Labeler: Mikart, Inc.
Product Type: Human Prescription Drug
Drug Name: Hydrocodone Bitartrate and Acetaminophen
Dosage Form: Oral Syrup
Application #: ANDA040881
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.

NDC Package Codes:

  • 46672-645-16: 473 ML IN 1 BOTTLE, PLASTIC (46672‑645‑16)

Active Ingredients:

  • Hydrocodone Bitartrate
  • Acetaminophen

Dosage Strength:

  • 10 mg/15mL
  • 300 mg/15mL

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.
  • 46672-192 Apap 300 mg / Hydrocodone Bitartrate 10 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.
  • 46672-052 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 ...

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