indomethacin

Generic: indomethacin

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler american health packaging
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

indomethacin 75 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-411
Product ID 68084-411_423d8198-e51f-90c2-e063-6294a90a1de7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079175
Listing Expiration 2026-12-31
Marketing Start 2010-03-26

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084411
Hyphenated Format 68084-411

Supplemental Identifiers

RxCUI
310992
UNII
XXE1CET956
NUI
N0000000160 M0001335 N0000175722

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 indomethacin (source: ndc)
Generic Name indomethacin (source: ndc)
Application Number ANDA079175 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-411-21) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-411-11)
source: ndc

Packages (1)

68084-411-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-411-21) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-411-11)

Ingredients (1)

indomethacin (75 mg/1)

Linked Drug Pages (1)

Indomethacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "423d8198-e51f-90c2-e063-6294a90a1de7", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["310992"], "spl_set_id": ["5a65b650-ea9b-4d0d-b62f-5971df1e62b4"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-411-21)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-411-11)", "package_ndc": "68084-411-21", "marketing_start_date": "20100326"}], "brand_name": "Indomethacin", "product_id": "68084-411_423d8198-e51f-90c2-e063-6294a90a1de7", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68084-411", "generic_name": "Indomethacin", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "75 mg/1"}], "application_number": "ANDA079175", "marketing_category": "ANDA", "marketing_start_date": "20100326", "listing_expiration_date": "20261231"}