diclofenac sodium misoprostol

Generic: diclofenac sodium and misoprostol

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

Drug Facts

Product Profile

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

diclofenac sodium 75 mg/1, misoprostol 200 ug/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-866
Product ID 71205-866_47a851b9-3e7f-4271-a2b8-ce836579729b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205143
Listing Expiration 2026-12-31
Marketing Start 2021-07-15

Pharmacologic Class

Established (EPC)
prostaglandin e1 analog [epc]
Chemical Structure
prostaglandins e, synthetic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205866
Hyphenated Format 71205-866

Supplemental Identifiers

RxCUI
857706 1359105
UPC
0371205866303 0371205865306
UNII
QTG126297Q 0E43V0BB57
NUI
N0000175785 M0017811

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 misoprostol (source: ndc)
Generic Name diclofenac sodium and misoprostol (source: ndc)
Application Number ANDA205143 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
  • 200 ug/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-00)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-30)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-55)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-60)
  • 240 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-64)
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-72)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-90)
source: ndc

Packages (7)

71205-866-00 100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-00) 71205-866-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-30) 71205-866-55 500 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-55) 71205-866-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-60) 71205-866-64 240 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-64) 71205-866-72 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-72) 71205-866-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-90)

Ingredients (2)

diclofenac sodium (75 mg/1) misoprostol (200 ug/1)

Linked Drug Pages (1)

Diclofenac Sodium Misoprostol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47a851b9-3e7f-4271-a2b8-ce836579729b", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0371205866303", "0371205865306"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105"], "spl_set_id": ["33f7db0b-f049-4d2e-abf5-4db97222e175"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-00)", "package_ndc": "71205-866-00", "marketing_start_date": "20220307"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-30)", "package_ndc": "71205-866-30", "marketing_start_date": "20220307"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-55)", "package_ndc": "71205-866-55", "marketing_start_date": "20220307"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-60)", "package_ndc": "71205-866-60", "marketing_start_date": "20220307"}, {"sample": false, "description": "240 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-64)", "package_ndc": "71205-866-64", "marketing_start_date": "20220307"}, {"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-72)", "package_ndc": "71205-866-72", "marketing_start_date": "20220307"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-90)", "package_ndc": "71205-866-90", "marketing_start_date": "20220307"}], "brand_name": "Diclofenac Sodium Misoprostol", "product_id": "71205-866_47a851b9-3e7f-4271-a2b8-ce836579729b", "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]", "Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "71205-866", "generic_name": "Diclofenac Sodium and Misoprostol", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium Misoprostol", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA205143", "marketing_category": "ANDA", "marketing_start_date": "20210715", "listing_expiration_date": "20261231"}