NDC 70518-2100

Cymbalta

Duloxetine Hydrochloride

Cymbalta is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Duloxetine Hydrochloride.

• Product ID: 70518-2100_8996c561-0f1c-604b-e053-2a95a90af5c2
• NDC: 70518-2100
• Product Type: Human Prescription Drug
• Proprietary Name: Cymbalta
• Generic Name: Duloxetine Hydrochloride
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-22
• Marketing Category: NDA / NDA
• Application Number: NDA021427
• Labeler Name: REMEDYREPACK INC.
• Substance Name: DULOXETINE HYDROCHLORIDE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-2100-0

30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-2100-0)

• Marketing Start Date: 2019-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-2100-0 [70518210000]

Cymbalta CAPSULE, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA021427
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-22

Drug Details

Active Ingredients

Ingredient	Strength
DULOXETINE HYDROCHLORIDE	20 mg/1

OpenFDA Data

• SPL SET ID: 71c5a674-f49f-423f-b1e2-af82bf947dfd
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 9044SC542W

Pharmacological Class

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

NDC Crossover Matching brand name "Cymbalta" or generic name "Duloxetine Hydrochloride"

NDC	Brand Name	Generic Name
0002-3235	Cymbalta	Duloxetine hydrochloride
0002-3240	Cymbalta	Duloxetine hydrochloride
0002-3270	Cymbalta	Duloxetine hydrochloride
21695-145	Cymbalta	Duloxetine hydrochloride
21695-146	Cymbalta	Duloxetine hydrochloride
68151-4734	Cymbalta	Cymbalta
68151-4679	Cymbalta	Cymbalta
21695-657	Cymbalta	Cymbalta
35356-843	Cymbalta	Cymbalta
43353-303	Cymbalta	Cymbalta
49999-618	Cymbalta	Cymbalta
52959-892	Cymbalta	Cymbalta
55289-028	Cymbalta	Cymbalta
55289-036	Cymbalta	Cymbalta
70518-2100	Cymbalta	Cymbalta
70518-2099	Cymbalta	Cymbalta
80425-0086	Cymbalta	Cymbalta
80425-0119	Cymbalta	Cymbalta
0904-7043	Duloxetine	Duloxetine Hydrochloride
0904-7044	Duloxetine	Duloxetine Hydrochloride
0904-7045	Duloxetine	Duloxetine Hydrochloride
0615-8034	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0615-8035	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0904-6452	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0904-6453	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0904-6454	Duloxetine Hydrochloride	Duloxetine Hydrochloride