diclofenac sodium delayed release

Generic: diclofenac sodium

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium delayed release
Generic Name diclofenac sodium
Labeler proficient rx lp
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-991
Product ID 71205-991_38aee69e-e66f-42b1-814a-551742b1a9cd
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 71205991
Hyphenated Format 71205-991

Supplemental Identifiers

RxCUI
855906 855926
UPC
0371205995300 0371205991302
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
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-00)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-11)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-30)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-55)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-60)
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-72)
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-78)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-90)
source: ndc

Packages (8)

71205-991-00 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-00) 71205-991-11 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-11) 71205-991-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-30) 71205-991-55 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-55) 71205-991-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-60) 71205-991-72 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-72) 71205-991-78 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-78) 71205-991-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-90)

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": "38aee69e-e66f-42b1-814a-551742b1a9cd", "openfda": {"upc": ["0371205995300", "0371205991302"], "unii": ["QTG126297Q"], "rxcui": ["855906", "855926"], "spl_set_id": ["afce2de2-0c59-4191-bf79-782ca31e427d"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-00)", "package_ndc": "71205-991-00", "marketing_start_date": "20200401"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-11)", "package_ndc": "71205-991-11", "marketing_start_date": "20200401"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-30)", "package_ndc": "71205-991-30", "marketing_start_date": "20200401"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-55)", "package_ndc": "71205-991-55", "marketing_start_date": "20200401"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-60)", "package_ndc": "71205-991-60", "marketing_start_date": "20200401"}, {"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-72)", "package_ndc": "71205-991-72", "marketing_start_date": "20200401"}, {"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-78)", "package_ndc": "71205-991-78", "marketing_start_date": "20200401"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-90)", "package_ndc": "71205-991-90", "marketing_start_date": "20200401"}], "brand_name": "Diclofenac Sodium Delayed Release", "product_id": "71205-991_38aee69e-e66f-42b1-814a-551742b1a9cd", "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": "71205-991", "generic_name": "Diclofenac Sodium", "labeler_name": "Proficient Rx LP", "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"}