indomethacin

Generic: indomethacin

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

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler ani pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

indomethacin 25 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-637
Product ID 70954-637_a2bb8e18-c1c2-4f73-ac4d-139a21488902
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217883
Listing Expiration 2027-12-31
Marketing Start 2024-01-12

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 70954637
Hyphenated Format 70954-637

Supplemental Identifiers

RxCUI
310991
UPC
0370954637103
UNII
XXE1CET956
NUI
N0000000160 M0001335 N0000175722

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 indomethacin (source: ndc)
Generic Name indomethacin (source: ndc)
Application Number ANDA217883 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70954-637-10) / 237 mL in 1 BOTTLE
source: ndc

Packages (1)

70954-637-10 1 BOTTLE in 1 CARTON (70954-637-10) / 237 mL in 1 BOTTLE

Ingredients (1)

indomethacin (25 mg/5mL)

Linked Drug Pages (1)

Indomethacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a2bb8e18-c1c2-4f73-ac4d-139a21488902", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0370954637103"], "unii": ["XXE1CET956"], "rxcui": ["310991"], "spl_set_id": ["e8b86758-6cb5-44ac-a5fc-2111e98a19a8"], "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": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70954-637-10)  / 237 mL in 1 BOTTLE", "package_ndc": "70954-637-10", "marketing_start_date": "20240112"}], "brand_name": "Indomethacin", "product_id": "70954-637_a2bb8e18-c1c2-4f73-ac4d-139a21488902", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70954-637", "generic_name": "Indomethacin", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "25 mg/5mL"}], "application_number": "ANDA217883", "marketing_category": "ANDA", "marketing_start_date": "20240112", "listing_expiration_date": "20271231"}