drizalma sprinkle

Generic: duloxetine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name drizalma sprinkle
Generic Name duloxetine
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
SUN PHARMACEUTICAL INDUSTRIES, INC.

Identifiers & Regulatory

Product NDC 47335-617
Product ID 47335-617_67134e3c-1819-4262-a36f-460afdbb165d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212516
Listing Expiration 2026-12-31
Marketing Start 2024-06-10

Pharmacologic Class

Classes
norepinephrine uptake inhibitors [moa] serotonin uptake inhibitors [moa] serotonin and norepinephrine reuptake inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335617
Hyphenated Format 47335-617

Supplemental Identifiers

RxCUI
2200168 2200174 2200175 2200177 2200178 2200180 2200181 2200183
UNII
9044SC542W

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name drizalma sprinkle (source: ndc)
Generic Name duloxetine (source: ndc)
Application Number NDA212516 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-10)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-90)
source: ndc

Packages (4)

47335-617-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-10) 47335-617-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-30) 47335-617-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-60) 47335-617-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-90)

Ingredients (1)

duloxetine hydrochloride (30 mg/1)

Linked Drug Pages (1)

DRIZALMA SPRINKLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "67134e3c-1819-4262-a36f-460afdbb165d", "openfda": {"unii": ["9044SC542W"], "rxcui": ["2200168", "2200174", "2200175", "2200177", "2200178", "2200180", "2200181", "2200183"], "spl_set_id": ["b41423b8-dfec-4d79-ba3c-e43a87803d85"], "manufacturer_name": ["SUN PHARMACEUTICAL INDUSTRIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-10)", "package_ndc": "47335-617-10", "marketing_start_date": "20240610"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-30)", "package_ndc": "47335-617-30", "marketing_start_date": "20240610"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-60)", "package_ndc": "47335-617-60", "marketing_start_date": "20240610"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-90)", "package_ndc": "47335-617-90", "marketing_start_date": "20240610"}], "brand_name": "DRIZALMA SPRINKLE", "product_id": "47335-617_67134e3c-1819-4262-a36f-460afdbb165d", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "47335-617", "generic_name": "Duloxetine", "labeler_name": "SUN PHARMACEUTICAL INDUSTRIES, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DRIZALMA SPRINKLE", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA212516", "marketing_category": "NDA", "marketing_start_date": "20240610", "listing_expiration_date": "20261231"}