diclofenac sodium and misoprostol (68001-231)

Drug Facts

Product Profile

Brand Name diclofenac sodium and misoprostol

Generic Name diclofenac sodium and misoprostol

Labeler bluepoint laboratories

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

diclofenac sodium 50 mg/1, misoprostol 200 ug/1

Manufacturer

BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-231

Product ID 68001-231_3e847cfc-d342-3a15-e063-6394a90aeb46

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201089

Listing Expiration 2026-12-31

Marketing Start 2014-02-26

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 68001231

Hyphenated Format 68001-231

Supplemental Identifiers

RxCUI

857706 1359105

UPC

0368001232067 0368001231060

UNII

QTG126297Q 0E43V0BB57

NUI

N0000175785 M0017811

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 and misoprostol (source: ndc)

Generic Name diclofenac sodium and misoprostol (source: ndc)

Application Number ANDA201089 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

50 mg/1
200 ug/1

source: ndc

Packaging

60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-231-06)

source: ndc

Packages (1)

68001-231-06 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-231-06)

Ingredients (2)

diclofenac sodium (50 mg/1) misoprostol (200 ug/1)

Linked Drug Pages (1)

Diclofenac Sodium and Misoprostol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3e847cfc-d342-3a15-e063-6394a90aeb46", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0368001232067", "0368001231060"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105"], "spl_set_id": ["9a22cb4b-e49a-4bd7-b235-47405c302658"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-231-06)", "package_ndc": "68001-231-06", "marketing_start_date": "20140226"}], "brand_name": "Diclofenac Sodium and Misoprostol", "product_id": "68001-231_3e847cfc-d342-3a15-e063-6394a90aeb46", "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": "68001-231", "generic_name": "Diclofenac Sodium and Misoprostol", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium and Misoprostol", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA201089", "marketing_category": "ANDA", "marketing_start_date": "20140226", "listing_expiration_date": "20261231"}