duloxetine

Generic: duloxetine

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler camber pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-168
Product ID 31722-168_232a4dda-8bb0-52fa-e063-6394a90ab09e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204343
Listing Expiration 2026-12-31
Marketing Start 2020-12-30

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 31722168
Hyphenated Format 31722-168

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0331722169301 0331722168601 0331722170307
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 duloxetine (source: ndc)
Generic Name duloxetine (source: ndc)
Application Number ANDA204343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-01)
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-05)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-10)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-30)
  • 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-168-31)
  • 105 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-168-32)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-90)
source: ndc

Packages (8)

31722-168-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-01) 31722-168-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-05) 31722-168-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-10) 31722-168-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-30) 31722-168-31 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-168-31) 31722-168-32 105 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-168-32) 31722-168-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-60) 31722-168-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-90)

Ingredients (1)

duloxetine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Duloxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "232a4dda-8bb0-52fa-e063-6394a90ab09e", "openfda": {"upc": ["0331722169301", "0331722168601", "0331722170307"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["b14feecc-04c6-4b2d-ba55-2e1dbef6b0d7"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-01)", "package_ndc": "31722-168-01", "marketing_start_date": "20201230"}, {"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-05)", "package_ndc": "31722-168-05", "marketing_start_date": "20240629"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-10)", "package_ndc": "31722-168-10", "marketing_start_date": "20201230"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-30)", "package_ndc": "31722-168-30", "marketing_start_date": "20201230"}, {"sample": false, "description": "7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-168-31)", "package_ndc": "31722-168-31", "marketing_start_date": "20201230"}, {"sample": false, "description": "105 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-168-32)", "package_ndc": "31722-168-32", "marketing_start_date": "20201230"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-60)", "package_ndc": "31722-168-60", "marketing_start_date": "20201230"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-90)", "package_ndc": "31722-168-90", "marketing_start_date": "20240629"}], "brand_name": "Duloxetine", "product_id": "31722-168_232a4dda-8bb0-52fa-e063-6394a90ab09e", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "31722-168", "generic_name": "Duloxetine", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204343", "marketing_category": "ANDA", "marketing_start_date": "20201230", "listing_expiration_date": "20261231"}