duloxetine delayed-release

Generic: duloxetine hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine delayed-release
Generic Name duloxetine hydrochloride
Labeler remedyrepack inc.
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0122
Product ID 70518-0122_47e297d1-dc2e-3f3b-e063-6294a90a5b53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203088
Listing Expiration 2027-12-31
Marketing Start 2017-01-13

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 705180122
Hyphenated Format 70518-0122

Supplemental Identifiers

RxCUI
596934
UNII
9044SC542W

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 delayed-release (source: ndc)
Generic Name duloxetine hydrochloride (source: ndc)
Application Number ANDA203088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70518-0122-5)
source: ndc

Packages (1)

70518-0122-5 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70518-0122-5)

Ingredients (1)

duloxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Duloxetine Delayed-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e297d1-dc2e-3f3b-e063-6294a90a5b53", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["b9f20917-9529-4c62-bafe-baae7f8d6c77"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70518-0122-5)", "package_ndc": "70518-0122-5", "marketing_start_date": "20241002"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "70518-0122_47e297d1-dc2e-3f3b-e063-6294a90a5b53", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "70518-0122", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "brand_name_suffix": "Delayed-Release", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20170113", "listing_expiration_date": "20271231"}