54868-5168 : Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup


NDC: 54868-5168
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name: Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage Form: Oral Syrup
Application #: ANDA040613
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.

NDC Package Codes:

  • 54868-5168-0: 1 BOTTLE IN 1 CARTON (54868‑5168‑0) > 473 ML IN 1 BOTTLE

Active Ingredients:

  • Homatropine Methylbromide
  • Hydrocodone Bitartrate

Dosage Strength:

  • 1.5 mg/5mL
  • 5 mg/5mL

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0121-1036 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution by Pai Holdings, LLC Dba Pai Pharma
  • 0121-4811 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Pharmaceutical Associates, Inc.
  • 0574-1105 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution by Paddock Laboratories, LLC
  • 10702-055 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Tablet by Kvk-tech, Inc.
  • 10702-150 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Liquid by Kvk-tech, Inc.
  • 13668-577 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution by Torrent Pharmaceuticals Limited
  • 17856-0043 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Atlantic Biologicals Corps
  • 17856-0455 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Atlantic Biologicals Corp.
  • 21695-869 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Rebel Distributors Corp
  • 40032-118 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Tablet by Novel Laboratories, Inc.
  • 40032-350 Homatropine Methylbromide 1.5 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Novel Laboratories, Inc.
  • 40032-810 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Novel Laboratories, Inc.
  • 43386-118 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Tablet by Gavis Pharmaceuticals, LLC
  • 43386-350 Homatropine Methylbromide 1.5 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Gavis Pharmaceuticals, LLC
  • 50383-043 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Hi-tech Pharmacal Co., Inc.
  • 59741-262 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution by Bio-pharm, Inc.
  • 60432-455 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Morton Grove Pharmaceuticals, Inc.
  • 60687-278 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by American Health Packaging
  • 64950-206 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Tablet by Genus Lifesciences Inc.
  • 64950-371 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution by Genus Lifesciences Inc.
  • More related products ...

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.