NDC 0998-0355

Mydriacyl

Tropicamide

Mydriacyl is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Tropicamide.

• Product ID: 0998-0355_0061a54d-79b7-48be-b889-b42de0624e33
• NDC: 0998-0355
• Product Type: Human Prescription Drug
• Proprietary Name: Mydriacyl
• Generic Name: Tropicamide
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1959-04-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA084306
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: TROPICAMIDE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0998-0355-15

1 BOTTLE in 1 CARTON (0998-0355-15) > 15 mL in 1 BOTTLE

• Marketing Start Date: 1959-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0998-0355-15 [00998035515]

Mydriacyl SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA084306
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1959-04-01

Drug Details

Active Ingredients

Ingredient	Strength
TROPICAMIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 0d4f4a2e-eb00-4c65-b3fa-baf5738d468d
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • N0A3Z5XTC6
• RxNorm Concept Unique ID - RxCUI:
  • 208660
  • 314238
• UPC Code:
  • 0309980355156

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]

NDC Crossover Matching brand name "Mydriacyl" or generic name "Tropicamide"

NDC	Brand Name	Generic Name
0065-0355	Mydriacyl	tropicamide
0998-0355	Mydriacyl	tropicamide
0404-7192	Tropicamide	Tropicamide
17478-101	Tropicamide	Tropicamide
17478-102	Tropicamide	Tropicamide
24208-585	Tropicamide	Tropicamide
24208-590	Tropicamide	Tropicamide
61314-354	Tropicamide	Tropicamide
61314-355	Tropicamide	Tropicamide
68071-4004	Tropicamide	Tropicamide
70069-121	Tropicamide	Tropicamide
70518-0744	Tropicamide	Tropicamide
70518-2759	Tropicamide	Tropicamide