diclofenac sodium delayed release (61442-103)

Drug Facts

Product Profile

Brand Name diclofenac sodium delayed release

Generic Name diclofenac sodium

Labeler carlsbad technology, inc.

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

diclofenac sodium 75 mg/1

Manufacturer

Carlsbad Technology, Inc.

Identifiers & Regulatory

Product NDC 61442-103

Product ID 61442-103_350d8fde-4096-17eb-e063-6394a90a9984

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075185

Listing Expiration 2026-12-31

Marketing Start 1998-11-13

Pharmacologic Class

Classes

anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] decreased prostaglandin production [pe] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61442103

Hyphenated Format 61442-103

Supplemental Identifiers

RxCUI

855906 855926

UPC

0361442103606 0361442102609

UNII

QTG126297Q

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 diclofenac sodium delayed release (source: ndc)

Generic Name diclofenac sodium (source: ndc)

Application Number ANDA075185 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

75 mg/1

source: ndc

Packaging

100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-01)
500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-05)
1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-10)
60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60)

source: ndc

Packages (4)

61442-103-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-01) 61442-103-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-05) 61442-103-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-10) 61442-103-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60)

Ingredients (1)

diclofenac sodium (75 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium Delayed Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "350d8fde-4096-17eb-e063-6394a90a9984", "openfda": {"upc": ["0361442103606", "0361442102609"], "unii": ["QTG126297Q"], "rxcui": ["855906", "855926"], "spl_set_id": ["40879600-ba6c-43a8-aa5d-d0d41503d593"], "manufacturer_name": ["Carlsbad Technology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-01)", "package_ndc": "61442-103-01", "marketing_start_date": "19981113"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-05)", "package_ndc": "61442-103-05", "marketing_start_date": "19981113"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-10)", "package_ndc": "61442-103-10", "marketing_start_date": "19981113"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60)", "package_ndc": "61442-103-60", "marketing_start_date": "19981113"}], "brand_name": "Diclofenac Sodium Delayed Release", "product_id": "61442-103_350d8fde-4096-17eb-e063-6394a90a9984", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "61442-103", "generic_name": "Diclofenac Sodium", "labeler_name": "Carlsbad Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "brand_name_suffix": "Delayed Release", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}], "application_number": "ANDA075185", "marketing_category": "ANDA", "marketing_start_date": "19981113", "listing_expiration_date": "20261231"}