diclofenac sodium delayed release

Generic: diclofenac sodium

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

Drug Facts

Product Profile

Brand Name diclofenac sodium delayed release
Generic Name diclofenac sodium
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 50 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4231
Product ID 68071-4231_1a3c5c49-b374-1318-e063-6394a90a47b6
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 680714231
Hyphenated Format 68071-4231

Supplemental Identifiers

RxCUI
855906
UPC
0368071423167
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
  • 21 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-1)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-3)
  • 45 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-5)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-6)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-9)
source: ndc

Packages (5)

68071-4231-1 21 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-1) 68071-4231-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-3) 68071-4231-5 45 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-5) 68071-4231-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-6) 68071-4231-9 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-9)

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": "1a3c5c49-b374-1318-e063-6394a90a47b6", "openfda": {"upc": ["0368071423167"], "unii": ["QTG126297Q"], "rxcui": ["855906"], "spl_set_id": ["629b77cf-f825-8640-e053-2991aa0a10a8"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-1)", "package_ndc": "68071-4231-1", "marketing_start_date": "20180112"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-3)", "package_ndc": "68071-4231-3", "marketing_start_date": "20180112"}, {"sample": false, "description": "45 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-5)", "package_ndc": "68071-4231-5", "marketing_start_date": "20180112"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-6)", "package_ndc": "68071-4231-6", "marketing_start_date": "20180112"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-9)", "package_ndc": "68071-4231-9", "marketing_start_date": "20180112"}], "brand_name": "Diclofenac Sodium Delayed Release", "product_id": "68071-4231_1a3c5c49-b374-1318-e063-6394a90a47b6", "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": "68071-4231", "generic_name": "Diclofenac Sodium", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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": "19981113", "listing_expiration_date": "20261231"}