NDC 0904-6454

Duloxetine Hydrochloride

Duloxetine Hydrochloride

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

• Product ID: 0904-6454_6566e7d5-91c3-4a9d-9680-7e3c8f6eae87
• NDC: 0904-6454
• Product Type: Human Prescription Drug
• Proprietary Name: Duloxetine Hydrochloride
• Generic Name: Duloxetine Hydrochloride
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-06-13
• Marketing End Date: 2022-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202045
• Labeler Name: Major Pharmaceuticals
• Substance Name: DULOXETINE HYDROCHLORIDE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0904-6454-61

100 BLISTER PACK in 1 CARTON (0904-6454-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2014-06-13
• Marketing End Date: 2022-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-6454-61 [00904645461]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA202045
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-06-13

Drug Details

Active Ingredients

Ingredient	Strength
DULOXETINE HYDROCHLORIDE	60 mg/1

OpenFDA Data

• SPL SET ID: 6684471a-6f95-439d-8d84-36d7e7d8eaf3
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 9044SC542W
• RxNorm Concept Unique ID - RxCUI:
  • 596930
  • 596934
  • 596926

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0615-7894	Duloxetine hydrochloride	Duloxetin hydrochloride
0615-7895	Duloxetine hydrochloride	Duloxetin hydrochloride
0615-8034	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0615-8035	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0615-8203	Duloxetine hydrochloride	Duloxetin hydrochloride
0615-8204	Duloxetine hydrochloride	Duloxetin hydrochloride
0615-8290	Duloxetine hydrochloride	Duloxetin hydrochloride
0904-6452	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0904-6453	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0904-6454	Duloxetine Hydrochloride	Duloxetine Hydrochloride
68788-9370	Duloxetine Hydrochloride	Duloxetine Hydrochloride
68788-9371	Duloxetine Hydrochloride	Duloxetine Hydrochloride
70518-0716	Duloxetine Hydrochloride	Duloxetine Hydrochloride
70518-0363	Duloxetine hydrochloride	Duloxetine hydrochloride
70518-0686	Duloxetine Hydrochloride	Duloxetine Hydrochloride
70518-1273	Duloxetine hydrochloride	Duloxetine hydrochloride
70518-1272	Duloxetine hydrochloride	Duloxetine hydrochloride
13668-110	Duloxetine hydrochloride	Duloxetine hydrochloride
13668-109	Duloxetine hydrochloride	Duloxetine hydrochloride
13668-111	Duloxetine hydrochloride	Duloxetine hydrochloride
33342-162	Duloxetine Hydrochloride	Duloxetine Hydrochloride
33342-160	Duloxetine Hydrochloride	Duloxetine Hydrochloride
33342-161	Duloxetine Hydrochloride	Duloxetine Hydrochloride
50090-3317	Duloxetine Hydrochloride	Duloxetine Hydrochloride
50436-2996	Duloxetine Hydrochloride	Duloxetine Hydrochloride
50436-2997	Duloxetine Hydrochloride	Duloxetine Hydrochloride
50436-0018	Duloxetine Hydrochloride	Duloxetine Hydrochloride
55154-7878	Duloxetine Hydrochloride	Duloxetine Hydrochloride
55700-165	Duloxetine Hydrochloride	Duloxetine Hydrochloride
55700-160	Duloxetine Hydrochloride	Duloxetine Hydrochloride
55700-435	Duloxetine Hydrochloride	Duloxetine Hydrochloride
60505-2997	Duloxetine Hydrochloride	Duloxetine Hydrochloride
60505-2996	Duloxetine Hydrochloride	Duloxetine Hydrochloride
60505-2995	Duloxetine Hydrochloride	Duloxetine Hydrochloride
61919-042	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE
61919-482	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE
63187-181	Duloxetine Hydrochloride	Duloxetine Hydrochloride
63187-457	Duloxetine hydrochloride	Duloxetine hydrochloride
63187-172	Duloxetine Hydrochloride	Duloxetine Hydrochloride
63187-716	Duloxetine Hydrochloride	Duloxetine Hydrochloride
64725-1100	Duloxetine hydrochloride	Duloxetine hydrochloride
55154-7889	Duloxetine Hydrochloride	Duloxetine Hydrochloride
0002-3235	Cymbalta	Duloxetine hydrochloride
0002-3240	Cymbalta	Duloxetine hydrochloride
0002-3270	Cymbalta	Duloxetine hydrochloride