ibuprofen oral

Generic: ibuprofen oral

Labeler: strategic sourcing services
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen oral
Generic Name ibuprofen oral
Labeler strategic sourcing services
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Strategic Sourcing Services

Identifiers & Regulatory

Product NDC 70677-1115
Product ID 70677-1115_19df0c73-0b7d-481c-b3c4-63baeef064f6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210602
Listing Expiration 2026-12-31
Marketing Start 2023-08-09

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 706771115
Hyphenated Format 70677-1115

Supplemental Identifiers

RxCUI
197803
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 oral (source: ndc)
Generic Name ibuprofen oral (source: ndc)
Application Number ANDA210602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70677-1115-1) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70677-1115-2) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

70677-1115-1 1 BOTTLE in 1 CARTON (70677-1115-1) / 118 mL in 1 BOTTLE 70677-1115-2 1 BOTTLE in 1 CARTON (70677-1115-2) / 237 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Ibuprofen Oral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19df0c73-0b7d-481c-b3c4-63baeef064f6", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["863f7ce3-b7b9-4c66-b351-5b95dd23dcb4"], "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": ["Strategic Sourcing Services"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70677-1115-1)  / 118 mL in 1 BOTTLE", "package_ndc": "70677-1115-1", "marketing_start_date": "20230809"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70677-1115-2)  / 237 mL in 1 BOTTLE", "package_ndc": "70677-1115-2", "marketing_start_date": "20230809"}], "brand_name": "Ibuprofen Oral", "product_id": "70677-1115_19df0c73-0b7d-481c-b3c4-63baeef064f6", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70677-1115", "generic_name": "Ibuprofen Oral", "labeler_name": "Strategic Sourcing Services", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen Oral", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210602", "marketing_category": "ANDA", "marketing_start_date": "20230809", "listing_expiration_date": "20261231"}