ibuprofen

Generic: ibuprofen

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler top care (topco associates llc)
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-193
Product ID 36800-193_427b861c-4464-a4b3-e063-6394a90aefb5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078682
Listing Expiration 2026-12-31
Marketing Start 2021-07-02

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 36800193
Hyphenated Format 36800-193

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 ANDA078682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-193-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-193-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-78)
  • 300 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-83)
source: ndc

Packages (4)

36800-193-11 1 BOTTLE in 1 CARTON (36800-193-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 36800-193-15 1 BOTTLE in 1 CARTON (36800-193-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 36800-193-78 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-78) 36800-193-83 300 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-83)

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": "427b861c-4464-a4b3-e063-6394a90aefb5", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["c6297c23-3b27-c0c6-e053-2995a90a3e76"], "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": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-193-11)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "36800-193-11", "marketing_start_date": "20210702"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-193-15)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "36800-193-15", "marketing_start_date": "20211229"}, {"sample": false, "description": "80 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-78)", "package_ndc": "36800-193-78", "marketing_start_date": "20210702"}, {"sample": false, "description": "300 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-83)", "package_ndc": "36800-193-83", "marketing_start_date": "20251031"}], "brand_name": "Ibuprofen", "product_id": "36800-193_427b861c-4464-a4b3-e063-6394a90aefb5", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "36800-193", "generic_name": "Ibuprofen", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA078682", "marketing_category": "ANDA", "marketing_start_date": "20210702", "listing_expiration_date": "20261231"}