ibu

Generic: ibuprofen

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

Drug Facts

Product Profile

Brand Name ibu
Generic Name ibuprofen
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 800 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3053
Product ID 68071-3053_1d8e3521-5b6d-3418-e063-6294a90a9c41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075682
Listing Expiration 2026-12-31
Marketing Start 2008-11-20

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 680713053
Hyphenated Format 68071-3053

Supplemental Identifiers

RxCUI
197807 206917
UPC
0368071305333
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 ibu (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA075682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BOTTLE (68071-3053-0)
  • 120 TABLET in 1 BOTTLE (68071-3053-1)
  • 20 TABLET in 1 BOTTLE (68071-3053-2)
  • 40 TABLET in 1 BOTTLE (68071-3053-4)
  • 60 TABLET in 1 BOTTLE (68071-3053-6)
source: ndc

Packages (5)

68071-3053-0 12 TABLET in 1 BOTTLE (68071-3053-0) 68071-3053-1 120 TABLET in 1 BOTTLE (68071-3053-1) 68071-3053-2 20 TABLET in 1 BOTTLE (68071-3053-2) 68071-3053-4 40 TABLET in 1 BOTTLE (68071-3053-4) 68071-3053-6 60 TABLET in 1 BOTTLE (68071-3053-6)

Ingredients (1)

ibuprofen (800 mg/1)

Linked Drug Pages (1)

IBU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d8e3521-5b6d-3418-e063-6294a90a9c41", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368071305333"], "unii": ["WK2XYI10QM"], "rxcui": ["197807", "206917"], "spl_set_id": ["678e2d16-33f3-67a7-e053-2991aa0a1132"], "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": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE (68071-3053-0)", "package_ndc": "68071-3053-0", "marketing_start_date": "20180316"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68071-3053-1)", "package_ndc": "68071-3053-1", "marketing_start_date": "20180316"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68071-3053-2)", "package_ndc": "68071-3053-2", "marketing_start_date": "20180316"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (68071-3053-4)", "package_ndc": "68071-3053-4", "marketing_start_date": "20180316"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68071-3053-6)", "package_ndc": "68071-3053-6", "marketing_start_date": "20180316"}], "brand_name": "IBU", "product_id": "68071-3053_1d8e3521-5b6d-3418-e063-6294a90a9c41", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68071-3053", "generic_name": "Ibuprofen", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IBU", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA075682", "marketing_category": "ANDA", "marketing_start_date": "20081120", "listing_expiration_date": "20261231"}