diclofenac sodium delayed release (61145-101)

Drug Facts

Product Profile

Brand Name diclofenac sodium delayed release

Generic Name diclofenac sodium

Labeler repharm llc

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

diclofenac sodium 50 mg/1

Manufacturer

REPHARM LLC

Identifiers & Regulatory

Product NDC 61145-101

Product ID 61145-101_a6c57ef9-36a1-413e-8266-fed804999cbb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075185

Listing Expiration 2026-12-31

Marketing Start 2017-09-27

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 61145101

Hyphenated Format 61145-101

Supplemental Identifiers

RxCUI

855906 855926

UPC

0361145101183 0361145101060 0361145101091 0361145102128 0361145102180 0361145102067

UNII

QTG126297Q

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

50 mg/1

source: ndc

Packaging

24 BOTTLE, PLASTIC in 1 BOX (61145-101-06) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
24 BOTTLE, PLASTIC in 1 BOX (61145-101-09) / 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
24 BOTTLE, PLASTIC in 1 BOX (61145-101-18) / 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

source: ndc

Packages (3)

61145-101-06 24 BOTTLE, PLASTIC in 1 BOX (61145-101-06) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 61145-101-09 24 BOTTLE, PLASTIC in 1 BOX (61145-101-09) / 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 61145-101-18 24 BOTTLE, PLASTIC in 1 BOX (61145-101-18) / 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

Ingredients (1)

diclofenac sodium (50 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": "a6c57ef9-36a1-413e-8266-fed804999cbb", "openfda": {"upc": ["0361145101183", "0361145101060", "0361145101091", "0361145102128", "0361145102180", "0361145102067"], "unii": ["QTG126297Q"], "rxcui": ["855906", "855926"], "spl_set_id": ["b2d71822-a7f3-447c-911c-971a21af5346"], "manufacturer_name": ["REPHARM LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "24 BOTTLE, PLASTIC in 1 BOX (61145-101-06)  / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "61145-101-06", "marketing_start_date": "20170927"}, {"sample": false, "description": "24 BOTTLE, PLASTIC in 1 BOX (61145-101-09)  / 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "61145-101-09", "marketing_start_date": "20170927"}, {"sample": false, "description": "24 BOTTLE, PLASTIC in 1 BOX (61145-101-18)  / 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "61145-101-18", "marketing_start_date": "20170927"}], "brand_name": "Diclofenac Sodium Delayed Release", "product_id": "61145-101_a6c57ef9-36a1-413e-8266-fed804999cbb", "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": "61145-101", "generic_name": "Diclofenac Sodium", "labeler_name": "REPHARM LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "brand_name_suffix": "Delayed Release", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}], "application_number": "ANDA075185", "marketing_category": "ANDA", "marketing_start_date": "20170927", "listing_expiration_date": "20261231"}