ibuprofen

Generic: ibuprofen

Labeler: proficient rx lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler proficient rx lp
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-213
Product ID 71205-213_caf36ae7-7d2e-4058-aa5b-35122c1187ab
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209207
Listing Expiration 2026-12-31
Marketing Start 2017-06-27

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 71205213
Hyphenated Format 71205-213

Supplemental Identifiers

RxCUI
197803
UNII
WK2XYI10QM
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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA209207 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71205-213-72) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

71205-213-72 1 BOTTLE in 1 CARTON (71205-213-72) / 120 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "caf36ae7-7d2e-4058-aa5b-35122c1187ab", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["b7565aac-a928-4116-b9af-cf636da4537c"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71205-213-72)  / 120 mL in 1 BOTTLE", "package_ndc": "71205-213-72", "marketing_start_date": "20190101"}], "brand_name": "Ibuprofen", "product_id": "71205-213_caf36ae7-7d2e-4058-aa5b-35122c1187ab", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "71205-213", "generic_name": "Ibuprofen", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA209207", "marketing_category": "ANDA", "marketing_start_date": "20170627", "listing_expiration_date": "20261231"}