ibuprofen

Generic: ibuprofen

Labeler: puracap pharmaceutical llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler puracap pharmaceutical llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
PuraCap Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 51013-103
Product ID 51013-103_b23cc43f-3c8b-496a-b6d4-eb260344372d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206568
Listing Expiration 2026-12-31
Marketing Start 2016-10-12

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 51013103
Hyphenated Format 51013-103

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 (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA206568 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (51013-103-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-22)
  • 1 BOTTLE, PLASTIC in 1 CARTON (51013-103-25) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (51013-103-26) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (51013-103-28) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-29)
  • 300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-31)
  • 200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-38)
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-39)
  • 400 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-41)
  • 800 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-42)
  • 1 BOTTLE in 1 CARTON (51013-103-63) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (12)

51013-103-15 1 BOTTLE, PLASTIC in 1 CARTON (51013-103-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 51013-103-22 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-22) 51013-103-25 1 BOTTLE, PLASTIC in 1 CARTON (51013-103-25) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 51013-103-26 1 BOTTLE, PLASTIC in 1 CARTON (51013-103-26) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 51013-103-28 1 BOTTLE, PLASTIC in 1 CARTON (51013-103-28) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 51013-103-29 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-29) 51013-103-31 300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-31) 51013-103-38 200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-38) 51013-103-39 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-39) 51013-103-41 400 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-41) 51013-103-42 800 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-42) 51013-103-63 1 BOTTLE in 1 CARTON (51013-103-63) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b23cc43f-3c8b-496a-b6d4-eb260344372d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["67e09ad5-e010-4aa1-b86e-9b22331bf33b"], "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": ["PuraCap Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (51013-103-15)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "51013-103-15", "marketing_start_date": "20161012"}, {"sample": false, "description": "60 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-22)", "package_ndc": "51013-103-22", "marketing_start_date": "20170516"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (51013-103-25)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "51013-103-25", "marketing_start_date": "20161012"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (51013-103-26)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "51013-103-26", "marketing_start_date": "20161012"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (51013-103-28)  / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "51013-103-28", "marketing_start_date": "20161012"}, {"sample": false, "description": "180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-29)", "package_ndc": "51013-103-29", "marketing_start_date": "20161012"}, {"sample": false, "description": "300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-31)", "package_ndc": "51013-103-31", "marketing_start_date": "20161012"}, {"sample": false, "description": "200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-38)", "package_ndc": "51013-103-38", "marketing_start_date": "20161012"}, {"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-39)", "package_ndc": "51013-103-39", "marketing_start_date": "20161012"}, {"sample": false, "description": "400 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-41)", "package_ndc": "51013-103-41", "marketing_start_date": "20170516"}, {"sample": false, "description": "800 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-42)", "package_ndc": "51013-103-42", "marketing_start_date": "20170516"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51013-103-63)  / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "51013-103-63", "marketing_start_date": "20170817"}], "brand_name": "Ibuprofen", "product_id": "51013-103_b23cc43f-3c8b-496a-b6d4-eb260344372d", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "51013-103", "generic_name": "Ibuprofen", "labeler_name": "PuraCap Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA206568", "marketing_category": "ANDA", "marketing_start_date": "20161012", "listing_expiration_date": "20261231"}