ibuprofen minis (58602-858)

Drug Facts

Product Profile

Brand Name ibuprofen minis

Generic Name ibuprofen

Labeler aurohealth llc

Dosage Form CAPSULE, LIQUID FILLED

Routes

ORAL

Active Ingredients

ibuprofen 200 mg/1

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-858

Product ID 58602-858_d0b03d99-477f-4250-ac84-576b1baf2eed

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA215777

Listing Expiration 2026-12-31

Marketing Start 2023-09-14

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 58602858

Hyphenated Format 58602-858

Supplemental Identifiers

RxCUI

310964

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 minis (source: ndc)

Generic Name ibuprofen (source: ndc)

Application Number ANDA215777 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (58602-858-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
1 BOTTLE in 1 CARTON (58602-858-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
1 BOTTLE in 1 CARTON (58602-858-23) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE
160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-30)
200 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-34)
240 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-42)
1 BOTTLE, PLASTIC in 1 CARTON (58602-858-70) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
1 BOTTLE, PLASTIC in 1 CARTON (58602-858-72) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
1 BOTTLE in 1 CARTON (58602-858-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-80)
1 BOTTLE, PLASTIC in 1 CARTON (58602-858-96) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-98)

source: ndc

Packages (12)

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen Minis ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "d0b03d99-477f-4250-ac84-576b1baf2eed", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["d0b03d99-477f-4250-ac84-576b1baf2eed"], "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": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-858-12)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "58602-858-12", "marketing_start_date": "20230914"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-858-18)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "58602-858-18", "marketing_start_date": "20230914"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-858-23)  / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "58602-858-23", "marketing_start_date": "20230914"}, {"sample": false, "description": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-30)", "package_ndc": "58602-858-30", "marketing_start_date": "20230914"}, {"sample": false, "description": "200 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-34)", "package_ndc": "58602-858-34", "marketing_start_date": "20230914"}, {"sample": false, "description": "240 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-42)", "package_ndc": "58602-858-42", "marketing_start_date": "20230914"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-858-70)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-858-70", "marketing_start_date": "20230914"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-858-72)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-858-72", "marketing_start_date": "20230914"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-858-73)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "58602-858-73", "marketing_start_date": "20230914"}, {"sample": false, "description": "200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-80)", "package_ndc": "58602-858-80", "marketing_start_date": "20230914"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-858-96)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-858-96", "marketing_start_date": "20230914"}, {"sample": false, "description": "240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-98)", "package_ndc": "58602-858-98", "marketing_start_date": "20230914"}], "brand_name": "Ibuprofen Minis", "product_id": "58602-858_d0b03d99-477f-4250-ac84-576b1baf2eed", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "58602-858", "generic_name": "Ibuprofen", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen Minis", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA215777", "marketing_category": "ANDA", "marketing_start_date": "20230914", "listing_expiration_date": "20261231"}