0121-4811 : Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup


NDC: 0121-4811
Labeler: Pharmaceutical Associates, Inc.
Product Type: Human Prescription Drug
Drug Name:  Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage Form: Oral Syrup
Application #: ANDA088008
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:

  • 0121-4811-05: 4 TRAY IN 1 CASE (0121‑4811‑05) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 5 ML IN 1 CUP, UNIT‑DOSE
  • 0121-4811-40: 4 TRAY IN 1 CASE (0121‑4811‑40) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 5 ML IN 1 CUP, UNIT‑DOSE (0121‑4811‑05)

Active Ingredients:

  • Hydrocodone Bitartrate
  • Homatropine Methylbromide

Dosage Strength:

  • 5 mg/5mL
  • 1.5 mg/5mL

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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.
  • 54868-5168 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Physicians Total Care, 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.
  • 66336-871 Homatropine Methylbromide 1.5 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Dispensing Solutions, Inc.

NDC QR Code

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NDC 0121-4811 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.