NDC 54799-431

HOMATROPINE HYDROBROMIDE

Homatropine Hydrobromide Ophthalmic

HOMATROPINE HYDROBROMIDE is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Ocusoft, Inc.. The primary component is Homatropine Hydrobromide.

• Product ID: 54799-431_1ce58581-b205-4c9e-b7a6-d2c80b597053
• NDC: 54799-431
• Product Type: Human Prescription Drug
• Proprietary Name: HOMATROPINE HYDROBROMIDE
• Generic Name: Homatropine Hydrobromide Ophthalmic
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-02-10
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: OCuSOFT, Inc.
• Substance Name: HOMATROPINE HYDROBROMIDE
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54799-431-05

5 mL in 1 BOTTLE, PLASTIC (54799-431-05)

• Marketing Start Date: 2014-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54799-431-05 [54799043105]

HOMATROPINE HYDROBROMIDE SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-02-10
• Marketing End Date: 2019-07-16

Drug Details

Active Ingredients

Ingredient	Strength
HOMATROPINE HYDROBROMIDE	50 mg/mL

OpenFDA Data

• SPL SET ID: 538ef499-28cb-a4d1-5f16-6e87ac4e07ac
• Manufacturer:
  • OCuSOFT, Inc.
• UNII:
  • BEW7469QZ0
• RxNorm Concept Unique ID - RxCUI:
  • 992757

Pharmacological Class

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

NDC Crossover Matching brand name "HOMATROPINE HYDROBROMIDE" or generic name "Homatropine Hydrobromide Ophthalmic"

NDC	Brand Name	Generic Name
54799-431	HOMATROPINE HYDROBROMIDE	HOMATROPINE HYDROBROMIDE OPHTHALMIC
59390-192	HOMATROPINE HYDROBROMIDE OPHTHALMIC	Homatropine Hydrobromide