NDC 58790-007

TheraTears Extra

Carboxymethylcellulose Sodium, Unspecified Form

TheraTears Extra is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Advanced Vision Research (subsidiary Of Akorn, Inc.). The primary component is Carboxymethylcellulose Sodium, Unspecified Form.

• Product ID: 58790-007_04a52c4f-0809-4a1a-a1d1-b8a600e6bb24
• NDC: 58790-007
• Product Type: Human Otc Drug
• Proprietary Name: TheraTears Extra
• Generic Name: Carboxymethylcellulose Sodium, Unspecified Form
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-04-16
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: Advanced Vision Research (Subsidiary of Akorn, Inc.)
• Substance Name: CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
• Active Ingredient Strength: 3 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 58790-007-15

1 BOTTLE, DROPPER in 1 CARTON (58790-007-15) > 15 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2018-04-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58790-007-15 [58790000715]

TheraTears Extra SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-04-16

Drug Details

Active Ingredients

Ingredient	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	2.5 mg/mL

OpenFDA Data

• SPL SET ID: 77f504c1-b8e0-4371-ac3e-9d453d84714b
• Manufacturer:
  • Advanced Vision Research (Subsidiary of Akorn, Inc.)
• UNII:
  • K679OBS311
• RxNorm Concept Unique ID - RxCUI:
  • 1547948
  • 2106821
• UPC Code:
  • 0358790007151

NDC Crossover Matching brand name "TheraTears Extra" or generic name "Carboxymethylcellulose Sodium, Unspecified Form"

NDC	Brand Name	Generic Name
58790-007	TheraTears Extra	Carboxymethylcellulose Sodium, Unspecified Form
58790-010	TheraTears Extra	Carboxymethylcellulose Sodium, Unspecified
76688-002	TheraTears Extra	Carboxymethylcellulose Sodium, Unspecified Form
69994-002	Biolle Gel Tears	Carboxymethylcellulose Sodium, Unspecified Form
69994-001	Biolle Tears	Carboxymethylcellulose Sodium, Unspecified Form
69183-205	Eyes Alive EYECON	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM