40032-350 : Homatropine Methylbromide 1.5 mg / Hydrocodone Bitartrate 5 mg Oral Tablet


NDC40032-350
Labeler: Novel Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name: Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage Form: Oral Tablet
Application #: ANDA091528
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: N;350
Shapes:  Round
Colors:  White
Size (mm): 8
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:

  • 40032-350-24: 100 TABLET IN 1 BOTTLE (40032‑350‑24)
  • 40032-350-26: 500 TABLET IN 1 BOTTLE (40032‑350‑26)

Active Ingredients:

  • Homatropine Methylbromide
  • Hydrocodone Bitartrate

Dosage Strength:

  • 1.5 mg
  • 5 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Anhydrous Dibasic Calcium Phosphate
  • Sodium Starch Glycolate Type a Potato
  • Silicon Dioxide
  • Magnesium Stearate

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.
  • 40032-118 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Tablet by Novel Laboratories, Inc.
  • 40032-810 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Novel Laboratories, Inc.
  • 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
  • 21695-869 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Syrup by Rebel Distributors Corp
  • 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.
  • 66336-871 Homatropine Methylbromide 1.5 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Dispensing Solutions, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 40032-350 QR Code

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