NDC 0378-3855

Escitalopram Oxalate

Escitalopram

Escitalopram Oxalate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Escitalopram Oxalate.

• Product ID: 0378-3855_6404ddfe-f72d-4237-aea2-542cd677467e
• NDC: 0378-3855
• Product Type: Human Prescription Drug
• Proprietary Name: Escitalopram Oxalate
• Generic Name: Escitalopram
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-02-29
• Marketing End Date: 2019-07-31
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021323
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ESCITALOPRAM OXALATE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0378-3855-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3855-77)

• Marketing Start Date: 2012-02-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3855-10 [00378385510]

Escitalopram Oxalate TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA021323
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-02-29
• Marketing End Date: 2014-09-05

NDC 0378-3855-77 [00378385577]

Escitalopram Oxalate TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA021323
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-29
• Marketing End Date: 2019-07-31

NDC 0378-3855-01 [00378385501]

Escitalopram Oxalate TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA021323
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-02-29
• Marketing End Date: 2014-09-05

NDC 0378-3855-93 [00378385593]

Escitalopram Oxalate TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA021323
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-29
• Marketing End Date: 2013-12-17

Drug Details

Active Ingredients

Ingredient	Strength
ESCITALOPRAM OXALATE	5 mg/1

OpenFDA Data

• SPL SET ID: 9a6c8116-396d-413b-b8e7-5eb321781bd5
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 5U85DBW7LO
• RxNorm Concept Unique ID - RxCUI:
  • 351250
  • 349332
  • 351249

Pharmacological Class

• Serotonin Reuptake Inhibitor [EPC]
• Serotonin Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "Escitalopram Oxalate" or generic name "Escitalopram"

NDC	Brand Name	Generic Name
0121-0852	Escitalopram Oxalate	Escitalopram Oxalate
0378-3855	Escitalopram Oxalate	escitalopram
0378-3856	Escitalopram Oxalate	escitalopram
0378-3857	Escitalopram Oxalate	escitalopram
68071-3283	Escitalopram Oxalate	Escitalopram Oxalate
68071-3312	escitalopram oxalate	escitalopram oxalate
68071-3265	escitalopram oxalate	escitalopram oxalate
68071-4210	escitalopram oxalate	escitalopram oxalate
68645-519	Escitalopram Oxalate	Escitalopram Oxalate
68645-520	Escitalopram Oxalate	Escitalopram Oxalate
68788-6978	escitalopram oxalate	escitalopram oxalate
69097-848	Escitalopram Oxalate	Escitalopram Oxalate
69097-849	Escitalopram Oxalate	Escitalopram Oxalate
69097-847	Escitalopram Oxalate	Escitalopram Oxalate
70518-0467	escitalopram oxalate	escitalopram oxalate
70518-0472	escitalopram oxalate	escitalopram oxalate
70518-0439	escitalopram oxalate	escitalopram oxalate
70518-1315	escitalopram oxalate	escitalopram oxalate
70518-0972	Escitalopram Oxalate	Escitalopram Oxalate
70518-0791	escitalopram oxalate	escitalopram oxalate
70518-1291	escitalopram oxalate	escitalopram oxalate
70518-1697	escitalopram oxalate	escitalopram oxalate
70934-060	escitalopram oxalate	escitalopram oxalate
70934-089	escitalopram oxalate	escitalopram oxalate
70934-163	escitalopram oxalate	escitalopram oxalate
71335-0685	escitalopram oxalate	escitalopram oxalate
76282-251	Escitalopram oxalate	Escitalopram oxalate
76282-249	Escitalopram oxalate	Escitalopram oxalate
76282-250	Escitalopram oxalate	Escitalopram oxalate
0904-6426	escitalopram oxalate	escitalopram oxalate
0904-6427	escitalopram oxalate	escitalopram oxalate
10544-968	Escitalopram Oxalate	Escitalopram Oxalate
10544-224	escitalopram oxalate	escitalopram oxalate
10544-230	escitalopram oxalate	escitalopram oxalate
10544-969	Escitalopram Oxalate	Escitalopram Oxalate
10544-225	escitalopram oxalate	escitalopram oxalate
13668-135	escitalopram oxalate	escitalopram oxalate
13668-137	escitalopram oxalate	escitalopram oxalate
13668-136	escitalopram oxalate	escitalopram oxalate
31722-569	Escitalopram Oxalate	Escitalopram Oxalate
33261-955	escitalopram oxalate	escitalopram oxalate
33342-036	Escitalopram Oxalate	Escitalopram Oxalate
33342-038	Escitalopram Oxalate	Escitalopram Oxalate
33342-037	Escitalopram Oxalate	Escitalopram Oxalate
43063-761	escitalopram oxalate	escitalopram oxalate
50090-2752	escitalopram oxalate	escitalopram oxalate
51079-544	Escitalopram Oxalate	Escitalopram Oxalate
51079-543	Escitalopram Oxalate	Escitalopram Oxalate
55154-5386	Escitalopram Oxalate	Escitalopram Oxalate
54838-551	Escitalopram Oxalate	Escitalopram Oxalate