NDC 70382-204

DEXTENZA

Dexamethasone

DEXTENZA is a Intracanalicular; Ophthalmic Insert in the Human Prescription Drug category. It is labeled and distributed by Ocular Therapeutix, Inc.. The primary component is Dexamethasone.

• Product ID: 70382-204_58f233d6-7061-416b-a627-ac63ceb3dc8a
• NDC: 70382-204
• Product Type: Human Prescription Drug
• Proprietary Name: DEXTENZA
• Generic Name: Dexamethasone
• Dosage Form: Insert
• Route of Administration: INTRACANALICULAR; OPHTHALMIC
• Marketing Start Date: 2019-01-07
• Marketing Category: NDA / NDA
• Application Number: NDA208742
• Labeler Name: Ocular Therapeutix, Inc.
• Substance Name: DEXAMETHASONE
• Active Ingredient Strength: 0 mg/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70382-204-01

1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) > 1 INSERT in 1 POUCH (70382-204-88)

• Marketing Start Date: 2019-01-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70382-204-10 [70382020410]

DEXTENZA INSERT

• Marketing Category: NDA
• Application Number: NDA208742
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-07

NDC 70382-204-01 [70382020401]

DEXTENZA INSERT

• Marketing Category: NDA
• Application Number: NDA208742
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-07

NDC 70382-204-99 [70382020499]

DEXTENZA INSERT

• Marketing Category: NDA
• Application Number: NDA208742
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-07

NDC 70382-204-88 [70382020488]

DEXTENZA INSERT

• Marketing Category: NDA
• Application Number: NDA208742
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-07

Drug Details

Active Ingredients

Ingredient	Strength
DEXAMETHASONE	.4 mg/1

OpenFDA Data

• SPL SET ID: 7514e6b8-c33f-4fbf-8810-ef520e1eb4bd
• Manufacturer:
  • Ocular Therapeutix, Inc.
• UNII:
  • 7S5I7G3JQL
• RxNorm Concept Unique ID - RxCUI:
  • 2108015
  • 2108020
• UPC Code:
  • 0370382204885

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "DEXTENZA" or generic name "Dexamethasone"

NDC	Brand Name	Generic Name
70382-204	DEXTENZA	DEXTENZA
0054-3177	Dexamethasone	Dexamethasone
0054-4179	Dexamethasone	Dexamethasone
0054-4180	Dexamethasone	Dexamethasone
0054-4181	Dexamethasone	Dexamethasone
0054-4182	Dexamethasone	Dexamethasone
0054-4183	Dexamethasone	Dexamethasone
0054-4184	Dexamethasone	Dexamethasone
0054-4186	Dexamethasone	Dexamethasone
0054-8174	Dexamethasone	Dexamethasone
0023-3348	OZURDEX	dexamethasone