ibuprofen pain reliever/fever reducer

Generic: ibuprofen

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen pain reliever/fever reducer
Generic Name ibuprofen
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-356
Product ID 65162-356_53da63da-f301-44dc-902c-2c288304929f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202300
Listing Expiration 2026-12-31
Marketing Start 2013-03-29

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 65162356
Hyphenated Format 65162-356

Supplemental Identifiers

RxCUI
310964
UPC
0365162356021
UNII
WK2XYI10QM
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 ibuprofen pain reliever/fever reducer (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA202300 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-356-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-11)
  • 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-50)
  • 1 BOTTLE in 1 CARTON (65162-356-69) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (4)

65162-356-02 1 BOTTLE in 1 CARTON (65162-356-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 65162-356-11 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-11) 65162-356-50 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-50) 65162-356-69 1 BOTTLE in 1 CARTON (65162-356-69) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen Pain Reliever/Fever Reducer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "53da63da-f301-44dc-902c-2c288304929f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0365162356021"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["877440fc-3afb-4123-a2e6-5cb48c74413c"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-356-02)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "65162-356-02", "marketing_start_date": "20130329"}, {"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-11)", "package_ndc": "65162-356-11", "marketing_start_date": "20130329"}, {"sample": false, "description": "500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-50)", "package_ndc": "65162-356-50", "marketing_start_date": "20130329"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-356-69)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "65162-356-69", "marketing_start_date": "20130329"}], "brand_name": "Ibuprofen Pain Reliever/Fever Reducer", "product_id": "65162-356_53da63da-f301-44dc-902c-2c288304929f", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "65162-356", "generic_name": "Ibuprofen", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "brand_name_suffix": "Pain Reliever/Fever Reducer", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA202300", "marketing_category": "ANDA", "marketing_start_date": "20130329", "listing_expiration_date": "20261231"}